Approved Prescription Drug Products with Therapeutic Equivalence Evaluations

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Approved prescription drug products with therapeutic equivalence evaluations. [Washington, D.C.?] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Bureau of Drugs : 1980- http://hdl.handle.net/2027/mdp.39015072932893

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.The L,'ni"é"¢~>;'3;;7,v of Michigan CUMULATIVE fl' Pharmacy Library SUPPLEMENT 1 3

- AUG ‘83 s|-:|> ‘as Y‘

ﬂAPPROVED ‘K? PRESCRIPTION SERIAL DRUG PRODUCTS 5%

WITH THERAPEUTIC EQUIVALENCE EVALUATIONS / Wnc/ 4T" EDITION;

.1115UN|VER m»? ‘OF.MICK-Haﬁz’!

NOV

0311M‘ 21 1983

Am: PHARMAC?‘ “BEAR! MINI-LIN" I

03180530 SBLVLS I» JO :IO A8

SBIHVHBI'I US. DEPARTMENT OF HEALTH AND HUMAN SERVICES @961 PUBLIC HEALTH SERVICE

3H1 FOOD AND DRUG ADMINISTRATION NATIONAL CENTER FOR DRUGS AND BIOLOGICS \OIUEINV NVEJIHOIW Y

item. that for supplements cumulative subsequent in dropped is >Jm2_>symbol The exists. information new which on line the of left the to >ADD>' symbol the by indicated are supplement cumulative current the to new Additions supplement. cumulative the in information new by indicated are List Product Drug the to Additions

ingredient(s). the of right the to located is List Product Drug the to referring parentheses A in number page context.) for repeated be not will publication the in exist already which (Strength(s) revision. the for List Product Drug the in place proper the locating in assist to completeness for supplement cumulative each in provided is products drug on information Context

one.) revised the of addition the by immediately followed is code equivalence therapeutic the of deletion the case that In revised. a is code equivalence therapeutic when exists exception infrequent (An source. single become has product drug the that indicates code equivalence a therapeutic of deletion the multisource; is product drug the that indicates code equivalence therapeutic any of presence The List. Product Drug the of format the follows supplement cumulative this in Information

month's previous supplement. cumulative l, the replaces supplement cumulative subsequent Each l983. August since made changes the include supplements cumulative List Product Drug The

LIST PRODUCT DRUG A.

referenced. be need supplement cumulative current and List the only way, this In confusion. possible avoid to discarded be supplements cumulative earlier that suggested also is It supplement. cumulative the in appear entry that to changes that indicate to Addendum the in name product the and List Product Drug the in ingredient(s) the of may left the to List the in (*) asterisk an place to wish Users supplement. cumulative current the without effectively used be cannot List The

Addendum. DESI the

and List Product Drug The lists: these of two to updates provide routinely are supplements cumulative The "list". term the by identified nature their by some and parts several of comprised is List The entirety. its in List the of cover publication annual the to revisions interim to List) (the Edition, ith Evaluations, Equivalence Therapeutic with Products Drug Prescription Approved a the to updates monthly of series of one is supplement cumulative This

PREFACE I.

SUPPLEMENT CUMULATIVE EVALUATIONS EQUIVALENCE THERAPEUTIC ITH PRODUCTS DRUG PRESCRiFTION APPROVED ADMINISTRATION DRUG AND FOOD Deletions from the Drug Product List are indicated by overstruck print in the cumulative supplement. Deletions new to the current cumulative ZLHL-> the supplement are indicated by the symbol (DELETE) to the left of >IHI-> line containing the overstruck print. The symbol is dropped in subsequent cumulative supplements for that item. by A newly approved product is identified the lozenge (I) to the right of its strength. This identifier remains throughout all cumulative supplements for this edition.

ADDENDUM: DESI Pending List

Information in this cumulative supplement follows the format of the Addendum. Additions and deletions are indicated in the same manner as in A the cumulative supplement to the Drug Product List. change in Current a a Status of DESI product is also indicated by an addition and deletion.

II. SPECIAL NOTES

REPORT OF COUNTS FOR THE DRUG PRODUCT LIST

the Categories of counts derived from product information in Drug Product List and from this cumulative supplement are presented. The report includes counts of new molecular entities approved by the agency during the current month.

SUBSCRIPTION FORM A subscription form for the publication has been provided at the end of this supplement for use in obtaining additional subscriptions.

ii III. REPORT OF COUNTS FOR THE DRUG PRODUCT LIST

DESCRIPTION OF REPORT

The following report provides summary counts derived from product information in the Drug Product List and the current cumulative supplement. The counts appear in two sections. Section A. refers to the products in the List and Section B. to products in the current cumulative supplement. A new column of data will appear in Section A. each three-month period following July '83. Section A. therefore will provide baseline and quarterly data while Section B. provides monthly activity.

USE OF REPORT

From the data presented under Section 8., users should be able to observe such things as (l) newly approved, DESI effective and remarketed drug products which are added to the List; (2) products that are being removed from the List as the result of withdrawal of approval, changes from prescription to over-the-counter status and discontinued marketing of products; and, (3) trends in approval of products as either multisource or single source during each month within the quarter. The report does not reflect category changes from multisource to single source and vice versa. However, the net gain that results from all additions, deletions and category changes is reflected in the quarterly counts for multisource and single source products.

Drug Product Definition

For this report, a drug product is the representation in the Drug Product List of an active moiety (includes molecular entity and its salts, esters and derivatives) either as a single entity or as a combination product, provided in a specific dosage form and strength for a given route of administration marketed by a firm under a particular generic or trade name.

New Molecular Entity

The active moiety has not previously been approved (either as the parent compound or as a salt, ester or derivative of the parent compound) in the United States for use in a drug product either as a single ingredient or part of a combination.

Drug Product Count

This report provides counts in several categories from the list composed of domestically marketed drug products approved for both safety and effectiveness under sections 505 and 507 of the Federal Food, Drug, and Cosmetic Act. Counts of products still pending in the DESI review are not provided. Excluded also are those approved drug products marketed by distributors; those marketed solely abroad; and products now regarded as medical devices, biologics or foods. Also not included in the counts are those duplicate products of a given applicant whose only distinguishing characteristics are items such as package size, inactive ingredient(s), color and alternate manufacturing sites. These various counts are excluded because the Drug Product List itself excludes products from these categories. Iv

LIST) THE OF l-5 PAGE (SEE COMPOSITION VARYING OF PRODUCTS ACID-CONTAINING AMINO (2) APPLICANT) ONE THAN MORE FROM AVAILABLE (I.e., PRODUCTS MULTISOURCE FOR ONLY PROVIDED EVALUATIONS EQUIVALENCE THERAPEUTIC (I)

I I 0 ENTITY THE OF DERIVATIVE OR ESTER SALT, A AS 0 O 0 ENTITY THE AS l l O APPROVED: ENTITIES MOLECULAR NEH 105 42 63 APPROVED PRODUCTS DRUG MULTISOURCE 27 19 8 APPROVED PRODUCTS SOURCE SINGLE 96 35 6) PRODUCTS DRUG IN GAIN NET 34 24 10 MARKETING DISCONTINUED 2 2 O SWITCH OTC TO RX O O 0 APPROVAL HITHDRAHN 36 26 IO REMOVED: PRODUCTS DRUG 3 2 I REMARKE'FED I l 0 EFFECTIVE DESI 128 58 70 APPROVED NEWLY 132 6| 7| ADDED: PRODUCTS DRUG

CUMULATIVE '83 SEPT '83 AUG

I NUMBER SUPPLEMENT FOR ACTIVITY B.

304 APPLICANTS OF NUMBER - APPROVED ENTITIES MOLECULAR NEH

(BASELINE) '83 JULY COUNTED CATEGORIES

QUARTERS BY CUMULATIVE COUNTS A.

LIST PRODUCT DRUG THE FOR COUNTS OF REPORT APPROVED PRESCRIPTION DRUG PRODUCTS 1 DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '63

AMINOPHYLLINE (PAGE 3-8) ASPIRIN; QARISOPRODQL (PAGE 3-16)

> OLT > /£i§ﬁi¢§/DPA£/ TABLET; ORAL > ADD > SOLUTION; ORAL SOMA COMPOUND > AOO > AMINOPHYLLINE WALLACE PHARMS/C-W 3ZSMG;ZOOMG! > AOO > A_ ROXANE LABORATORIES LOSUS-SULU

TABLET; ORAL ASPIRINI,CARISOPRODOLifCODEINE PHOSPHATE (PAGE 3-16) AMINOPHYLLINE > ADD > 80 BARR LABORATORIES looms: TABLET; ORAL > ADD > 80 zoonen SOMA COMPOUND W/ CODEINE WALLACE PHARMS/C-W 325MG;200MG;16MG!

> ADD > ASPIRIN; BUTALBITAL; CAFFEINE (PAGE 3—15) ASPIRIN; HYDROCODONE BITARTRATE (PAGE 3-16) > TABLET; ORAL > ADD > ASPIRIN AND CAFFEINE W/ BUTALBITAL TABLET; ORAL > PUREPAC/KALIPHARMA 325MG;50MG;40MG! VICODIN KNOLL PHARMACEUTICAL 500MG;5MG!

ASPIRIN; BUTALBITAL; CAFFEINE; PHENACETIN (PAGE 3-15) BACAMPICILLIN HYDROCHLORIDE (PAGE 3-18) TABLET; ORAL .P.°. WI BUTALBITAL TABLET; ORAL > on MY ﬁapazammiapxm/ mmssmaimamma/ SPECTROBID PFIZER LABS-PFIZER BOOMG!

> ADD > ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE (PAGE 3-15) BETAMETHASONE VALERATE (PAGE 3-21)

> ADD > CAPSULE; ORAL

> ADD > SYNALGOS-DC CREAM; TOPICAL

> ADD > IVES LABS/AMHO 356.4MG;30MG;16MGI V > U BETAMETHASONE VALERATE

V D D E FOUGERA/BYK—GLDN EQ 0.12 BASE! V > U PHARMADERM/BYK-GLDN IEHG EQ 0.12 BASE! V > ASPIRIN; CAFFEINE; PHENACETIN; PROPOXYPHENE HYDROCHLORIDE U QEIAIKE! V VVVVV (PAGE 3-15) ]> U 13 SAVAGE LABS/BYK-GLDN EQ 0.12 BASE!

CAPSULE; ORAL LOTION; TOPICAL V PROPOXYPHENE counounn 65 3) U U BETAMETHASONE VALERATE - > D O , , V O E OLT >/AA L éffléiiéldfidiidédéiéfiflé/ FOUGERA/BYK-GLDN EQ 0.12 BASE! V > > b O O PHARMADERM/BYK—GLDN BASE! OLT lééfird'ddfiéddfld'éé ENG EQ 0.12 > > DLT 46 r . . ,LABS/lééifldiéélddéiiéifldiééfié/ V > U U QEIAIEEK V VVVVV > O O > U LT >/_—/ /§K£é$'édfi¢ddfld 13 SAVAGE LABS/BYK—GLDN EQ 0.12 BASE!

> OLT >/é§/ ,L ,ORIES/ lééffiéfiéldfléii6éfléié$flél EALZ§£§§

V > U U V 15 SCHERING EQ 0.12 BASE

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE (PAGE 3-16) OINTMENT; TOPICAL V > U U BETAMETHASONE VALERATE > U U CAPSULE; ORAL V E FOUGERA/BYK-GLDN :9 0.12 BASE!

DARVON COMPOUND-65 V > U U PHARHADERM/BYK-GLDN 0.12 EASEU ISIS EQ V > > > U ADD AA ELI LILLY INDSTRS-PR 389MG;52.¢MG;65MG U QEIAIEE! VVVVV V > > ADD SK—65 COMPOUND > U U 15 SAVAGE LABS/BYK-GLDN Eg 0.1z BASE!

> ADD > A_ SK&F LABORATORIES 389MG;52.4MG;65MGI URLESQUE > V U U V 13 SCHERING EQ_QELZ_EA§E > BASE-VIAL! 26M EQ > ADD > BASE-VIAL! IGM EQ LABORATORIES SK&F > ADD > 0.252! HOECHST-ROUSSEL CEFIZOX > ADD

TOPICORT INJECTION INJECTABLE; > ADD > TOPICAL OINTMENT;

3-30) (PAGE SODIUM CEFTIZOXIME > ADD > 3-49) (PAGE DESOXIMETASONE

IIGMIIOOML! > ADD > > > ldlifié-hfl/ DAVIS/N-L PARKE >/ég/ OLT > 200MG/100ML;9.4GM/100ML; ADD

SYTOBEX 510MG/100ML;5°GM/100ML; > ADD > > > ldIiHé/Hﬁ MS-D-MERCK >/é£/ DLT > 9.66M/100ML! ADD

REDISOL 200MG/100ML;9.ZGM/100ML; > ADD > > INJECTION INJECTABLE; 510MG/100ML;5°GM/100ML HOSP MCGAN/AM AM > ADD

CONTAINER PLASTIC IN 502 DEXTROSE W/ CONCENTRATE DIALYTE > ADO >

3-44) (PAGE CYANOCOBALAMIN IIGM/IOOML! > ADD >

200MG/100ML;9.4GM/100ML; > ADD >

510MG/100ML;3OGM/100ML; > ADD > > > > 250MG! PHARMACEUTICAL PAR A ADD 9.6GM/100ML! >. ADD > CHLORZOXAZONE 200MG/100ML;9.ZGM/100ML; > ADO > ORAL TABLET; 510MG/100ML;3OGM/100ML; HOSP MCGAN/AM AM > ADD ) CONTAINER PLASTIC IN 302 DEXTROSE W/ CONCENTRATE DIALYTE > ADD 3-39) (PAGE CHLORZOXAZONE INTRAPERITONEAL SOLUTION;

3-26) (PAGE CHLORIDE SODIUM ACETATE‘ > > 50MB! PUREPAC/KALIPHARMA A ADD SODIUM CHLORIDE’ MAGNESIUM DEXTROSE‘ CHLORIDE‘ CALCIUM QHLQBIUALIDQEE ORAL TABLET; liéfiéiiddfiéiiédflé/ Rfl$/¢§fl/ LL >/é§/ OLT > 3-38) (PAGE CHLORTHALIDONE /SOHA'OOHROUNO > DLT > ORAL TABLET; . .

L CAFFEINE; >/4_4/ >__DLT 3-25) (PAGE PHENACETIN CARISOPRODOL; MALEATE CHLORPHENIRAMINE ORAL TABLET;

> > II; 3-36) (PAGE MALEATE CHLORPHENIRAMINE ARQSAIIIAAM:AAAAAOAAARAAAA/15/ A .' TIA'I-‘OIIPDTINR'IIISIAAIWA'AA > > lffiéifis'fdéfii/ > w > V V 500MB! U U > 3'24) (PAGE V > V ISIS O 250MB! LABORATORIES CHELSEA O /OA¢¢E1HE§'OAR£§6RROOOE§'dddéiflé'ifldéifléfég‘RHEHAOEfiN/ > OLT > CHLOROTHIAZIDE ORAL TABLET; 0.752;0.0091MG/ML! A! > ADD > 3-35) (PAGE CHLOROTHIAZIDE 0.52;0.0091MG/ML! PHARM HOSP ASTRA A! > ADD > SEHSOROAIHE > ADD > 0.752;0.0091MG/ML A! > ADD > V 30MB! ROCHE HOFFMANN-LA U U > 0.52;0.0091MG/ML LABS-STERLING BREON A! > ADD > LIBRELEASE EPINEPHRINE NI HOL MAROAIHE VVV VV ORAL RELEASE; CONTROLLED CAPSULE; CO CO >> INJECTION INJECTABLE;

3-33) (PAGE CHLORDIAZEPOXIDE 3-23) (PAGE BITARTRATE EPINEPHRINE HYDROCHLORIDE; BUPIVACAINE

'83 SEPTEMBER & '83 AUGUST / 1 NUMBER SUPPLEMENT CUMULATIVE / LIST PRODUCT DRUG / / & DRUG PRODUCT LIST CUMULATIVE SUPPLEMENT NUMBER 1 AUGUST '83 SEPTEMBER '83

DEXAMETHASONE (PAGE 3-49) DISULFIRAM (PAGE 3-63)

SOLUTION; ORAL TABLET; ORAL DEXAMETHASONE DISULFIRAM V > ROXANE LABORATORIES 0.5MG/5ML! U BX CHELSEA LABORATORIES ZSOMG! V VV DEXAMETHASONE INTENSOL > U BX SOOMG! ROXANE LABORATORIES 0.5MG/0.5ML!

TABLET; ORAL DOXYCYCLINE HYCLATE (PAGE 3-64) DECADRON > ADD > BP MS-D-MERCK 6M6 CAPSULE; ORAL DEXAMETHASONE DOXYOYOLIHE HYCLATE V A O BP ROXANE LABORATORIES 6M6! AB CHELSEA LABORATORIES EQ 50MB BASE V > U 1M6!

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE (PAGE 3-66) DEXAMETHASONE SODIUM PHOSPHATE (PAGE 3-50) INJECTABLE; INJECTION V > INJECTABLE; INJECTION U LIDOCATON V /HERAOROL'RHOS¢HATE/ > U AG PHARMATON-SZ 0.01us/mlzggu VVV > HEXADROL V U AG o.ozualnl:ggu V > U AG ORGANONIAKZONA EQ 6M6 PHOSPHATE-ML V > U VV EQ zone PHOSPHATE-ML ERYTHROMYCIN (PAGE 3-67)

DEXTROSE; DOPAMINE HYDROCHLORIDE (PAGE 3-53) OINTMENT; OPHTHALMIC V > O ERYTHROHYOIH V > U A; E FOUGERA/BYK-GLDN sue-sun INJECTABLE; INJECTION I V VVV V UFq /D¢PAHIN£.H¢L.1N.P¢XIR¢$£.$2/ > U A; PHARHADERM/BYK-GLDN BUS-SUN V >UU DOPAMINE HOL ILOTYCIN V V V > U U ABBOTT LABORATORIES 5OM/100ML280MS/100ML ) - A; OISTA PRODS-LILLY Sggggg V U > U SGH/100ML;160HG/100HL ISIS V > U U DOPAHINE HOL IN RLASTIO CONTAINER V A D U ABBOTT LABORATORIES SGH/100HL;80MG/500HLI SENTAHICIN SULFATE (PAGE 3-79) V U D A

ISIS SGM/IOOHL3160MG/100HL! VVVVVVVV V > U U 56M/100ML;320M6/100ML! CREAM TOPICAL V > U GEHTAFAIR V - U AI PHARMAFAIR EQ_IHE_QA§E£EHP V > DIETHYLPROPION HYDROCHLORIDE (PAGE 3-59) U GEHTAHIOIH SULFATE V VVVV > U A; NMC LABORATORIES §g_;g§_BA§§4§gn TABLET; ORAL DIETHYLPROPION "BL INJECTABLE; INJECTION 55 CAMALL 25MB! GENTAHIOIN SULFATE V > U U AG . ABBOTT LABORATORIES :9 sons BASE/JOOMLA V A O U AG EQ 70MB BASEIOOHL! V DIPHENHYDRAMINE HYDROCHLORIDE (PAGE 3-61) > U U 93 E sows BASEIIOOMLI > V U U A! EQ 9056 BASE/IODML!

CAPSULE; ORAL V A D U QB EQ IOCHG BASEIIODML!

SK-DIPHEHHYDRAMINE V > O U 5! Eg 1.2MG BASE-ML! > > OLT >léé/ SK&F LABORATORIES lééﬁé/ V U U A! EQ 1.4MG BASE-ML!

V )5 D O AG EQ 1.6MG BASE-ML! V > U U ELIXIR; ORA L QB EQ 1.8HS BASE-ML! p V > > U on /SK-‘OIRTIETITHIIRATIITIE - AG 59 2B3 BASE-NLU V >_Di>/é.é/ .J- . S/ liélériélémll > U U 53 E 10MB BASE-ML! V > U U AG EQ Q HG BASE-ML! v VVVVVVVVVVVVV > D C QB LYPHO-MED EQ QOHG BASE-ML! Erma" AB > Ann > 25MB! AB > ADD > 2.52: AT > AOO > 10MB! PHARMACAL DANBURY AB > AOO > 13! LABORATORIES BAY 51 > ADD > HOL HYDROXYZINE NYOROOORTISONE ORAL TABLET; TOPICAL CREAM;

3-96) (PAGE HYOROORLORIOE UYOROXYZINE 3-90) (RASE HYDROCORTISONE

0.22: PHARMS NESTNOOO > ADD > zsuszzsnsn PUREPAC/QUALIPHARMA AB > ADD > NEsTcoRT > AOO > HYDROOHLOROTHIAZIUE RI SPIRONOLACTONE TOPICAL OINTMENT; > AOO > ORAL TABLET;

3'95) (PAGE UIQEQQQBII§QNE_MALEBAIE 3-89) (PAGE SPIRONOLACTONE HYDROCHLOROTHIAZIDE;

/¢.$2/, /HSAR-HKR-K/ > BLT > some: PUREPAC/KALIPHARMA AG > AOO > lHXRRRCdRIdNE/ > OLT > 100MB! PHARMACEUTICAL PAR 55 > AOO > ISUSPENSIRN/RRRP$5ZRPHIHAIHI¢JIRII¢I > OLT > HOL HYDRALAZINE ORAL TABLET; >___w 14I 7.?BIINEfPZIiI-‘3EN7 >/At/ AdEfAfE lﬁfdRdddRfISdNE > OLT > 3-86) (PAGE HYDROCHLORIDE HYDRALAZINE 0.52 PHARM’ INGRAM >/é1/ DLT > ORIOORT TOPICAL LOTION; lidfid/ L >/é§/ OLT > SE /SEOS-TENS > DLT > 10MB PHARMACAL MISSION DLT > lizl 733RAEYFZU£33R7 >_2LI_>/éI/ >léé/ ACETATE HYDROCORTISONE HOMAPIN-IO TOPICAL CREAM; ORAL TABLET;

3-93) (PAGE ACETATE HYDROCORTISONE 3-86) (PAGE METHYLBROMIDE HOMATROPINE ; UNITS-ML! BASElHL;10;000 5.5MG IG-EG LABS CARTER-GLOGAU AL > ADD > lSiddd'UHifSlVidi/ 'ISIHEI/ >/é£/ OLT > NEO-OTOSOL—HC > AOO > /S RIN /INTUIT > DLT > SOLUTION/DROPS;.OTIC INJECTABLE;'INJECTION

3-92) (PAGE SULFATE B POLYMYXIN SULFATE; NEOMYCIN HYDROCORTISONE; 3-81) (PAGE CHORIONIC GONADOTROPIN I'i

lfiléfi/ BASEIIUOML! 80MB EQ A! > ADD ) lupin/ BASE-ML! 0.8MG EQ LABS TRAVENOL A! > ADD > OLT > CONTAINER PLASTIC IN SULFATE GENTAMICIN ISOTONIC BASE-ML! 2M6 EQ A! > ADD > 2.52: A_ > Ann > BASE-ML! I.8HG EQ A! ) ADD > 1;: LABORATORIES BAY 51 > ADD > BASE-ML! 1.6MG EQ A! > ADD > EIQBQQQBIIEQNE BASE-ML! 1.4MG EQ A! > ADD > TOPICAL OINTMENT; BASE-ML! 1.2MG EQ A! > ADD > BASEIIOOML! 100MB Eg 5! > ADD > /§Z§Z/ lfflflNEIPAUiSEN/ 31/ >_QLI_> BASE/IDOHL! 90MB EQ A! ) ADD > 0.52 INDUSTRIES MERICON AT > ADD > BASE/IDOHL! 80MB EQ AB > ADD > EHYDROCCRTISON BASE/IDOHL! 70MB EQ A! > ADD > léiéi/ >_QL1_>/éi/ BASEIIOOML! 60MB EQ LABORATORIES ABBOTT A! > ADD > ‘7HEPIEBNI1NRRSIRIES//OELAOORT > OLT > CONTAINER PLASTIC IN SULFATE GENTAMICIN > ADD > TOPICAL LOTION; INJECTION INJECTABLE;

3-90) (PAGE HYDROCORTISONE 3-79) (PAGE SULFATE GENTAMICIN

4 '83 SEPTEMBER & ‘83 AUGUST / 1 NUMBER SUPPLEMENT CUMULATIVE / LIST PRODUCT DRUG DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '83

HYDROXYZINE PAMOATE (PAGE 3-96) METRONIDAZOLE (PAGE 3-122)

CAPSULE; ORAL INJECTABLE; INJECTION

HYDROXYZINE PAMOATE > ADD > METRO I.V. IN PLASTIC CONTAINER > ADD > 5Q VANGARD LABS-MN" EQ ZSHG HOLN > ADD > A! AM MCGAN/AM HOSP SOOHG/lOOML! > ADD > 99 E9 SONG HcLu TABLET; ORAL DEIBQEIQAZQLE

IMIPRAMINE HYDROCHLORIDE (PAGE 3-97) > ADD > AB PAR PHARMACEUTICAL 250MB!

> ADD > AB SONG!

> DLT > ‘AREAS, , > BLT > LBP/ /L-NN-N/ /25N¢/ > ADD > NANDROLONE DECANOATE (PAGE 3-125) > on > OLT U“> HAMMERING, MM > ADD > INJECTABLE; INJECTION > > >AL>/_/ 33/ /_1/ ADD NANDROLONE DECANOATE

> ADD > MAURRY BIOLOGICAL IOOMG/ML!

ISOETHARINE HYDROCHLORIDE (PAGE 3-100) NITROGLYCERIN (PAGE 3-128) SOLUTION; INHALATION ISOETHARIHE HOL INJECTABLE; INJECTION

> ADD > A! INTL MEDICATION SYS 0.1672 > ADD > HITRONAL > > > > ADD 95 ROXANE LABORATORIES 0.1672! ADD A! G POHL-BOSKAMP ENG-ML! > > > > ADD 95 TRAVENOL LABS 0.252! ADD IMG-ML! TRIDIL > ADD > AM CRITICAL CARE-AHS O.5MG/ML! KANAMYCIN SULFATE (PAGE 3-102)

INJECTABLE; INJECTION OXTRIPHYLLINE (PAGE 3-131)

> ADD > KANAHYOIN SULFATE > > ADD INTL MEDICATION SYS EQ 500MB BASE-2ML! TABLET, ENTERIC COATED; ORAL > > ADD 'U. IGH CHOLEDYL |>|> EQ BASEISHLH KANTREX > ADD > AB PARKE-DAVIS/N—L IOOMG I "' I q > > V A ‘U~ U r —7BRI§I¢L.Lﬁ¢$/BrH/ ADD AB 200MB > V ;g%3%:ﬁNL/.1 } ‘.I‘IIZ/ ADD > OXTRIPHYLLINE > > V DO r-r 4-4 liéfilzfilf ADD AB BOLAR PHARMACEUTICAL 100MB! > > “<&& V P U U BRISTOL LABS/B-M EQ 75HG BASEIZHL ADD AB 200MB! v V > U U EQ 500MB BASEIZML E > U 11" o V v |>I>|>|ij\>~ 16" BASEISML OXYTETRACYCLINE HYDROCHLORIDE (PAGE 3-132)

LIDOCAINE HYDROCHLORIDE (PAGE 3-104) CAPSULE; ORAL

> OLT > /OREOPAR INJECTABLE; INJECTION >_Qll_>/é§/ A PDAVIS/NFI/ léﬁléééﬁé'édéél LIOOOATON VV VV CO CO 9 >) _g PHARMATON-SZ ggu

PENICILLIN V POTASSIUM (PAGE 3-135)

METHYLTESTOSTERONE (PAGE 3-121) PONDER FOR RECONSTITUTION; ORAL > DLT > /UIIOILLIN'VK

TABLET; > > AA BUCCAL-SUBLINGUAL DLT YflFJBHI?I Ed'flééfié'dAsE/SNL/

METHYLTESTOSTERONE > DLT >I§ZI IEOAB fiéfEAELIS Ll > > OLT LBP/ LIDNNEXPADLSEN/ lififié/ M‘P'fi/ ISIIIIYIITL'NYIIXIII lflfl/

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SREEOOEESE REESE sOvT HTVONUHJ vv < oov < TVBO :DNAAS aIvaIavI anzzvaIauxouaua Ivan :IITQVI (SST-2 39Vd) BOIBOTHOOBOAR BNIOITOaaIaI .BOIaOTNOOaOAN aNIaOaHdaOOnaSd (BET-E 39Vd) BIVUIUVI aNIzvaIaNIoNaNd / ‘3 I / 9 £9. UBBHHIEIHS £9. .LSI'ISOV UHBNDN .LNBNBTddﬂS BAIIV'IONDD LSI'I .LOFLOOUD SOHO DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '83

SPIRONOLACTONE (PAGE 3-166) THIORIDAZINE HYDROCHLORIDE (PAGE 3-178)

TABLET; ORAL TABLET: ORAL SPIRONOLACTONE DELLABIL > ADD > AB PUREPAC/QUALIPHARMA 25MB! > ADD > 99 SANDOZ PHARMS-SANDOZ IOOMG THIORIDAZINE HCL > ADD > 99 BOLAR PHARMACEUTICAL IONG! TESTOSTERONE (PAGE 3-173) > ADD > 99 Ioousu > ADD > 99 CORO LABORATORIES 10MB! INJECTABLE; INJECTION > ADD > 99 15MB! TESTOSTERONE > ADD > 99 25MB! > ADD > CARTER-GLOGAU LABS SONG-ML! > ADD > 99 SOHO!

TETRACYCLINE HYDROCHLORIDE (PAGE 3-174) TIMOLOL MALEATE (PAGE 3-179)

TABLET; ORAL TABLET; ORAL PAHHYOIN BLOCADREN > DLT >/99/ UPJOHN léSdNS/ > ADD > MS-D-MERCK SMG SUMYCIN > DLT >/99/ ER SQUIBB AND SONS 250MB TRIAMCINOLONE ACETONIDE (PAGE 3-180)

THEOPHYLLINE (PAGE 3-176) CREAM; TOPICAL TRIAMCINOLONE ACETONIDE CAPSULE; CONTROLLED RELEASE; ORAL > ADD > 91 BAY LABORATORIES 0.0252u SOMOPHYLLIN-CRT > AOO > 91 0.12: > ADD > BC FISONS IOOMG > ADD > 91 0.szu > ADD > THEO-24 > ADD > BC SEARLE-SEARLE PHARMS IOOMG! OINTMENT; TOPICAL > ADD > 2OOMG! TRIAMCINOLONE AOETONIOE > ADD > 3OOMG! > AOO > 91 BAY LABORATORIES 0.0252: > ADD > 9; 0.12m SOLUTION; ORAL > ADD > 91 0.529 THEOLAIR > ADD > AA RIKER LABS-3M 80MG-15ML > ADD > THEOPHYLLINE TRISULFAPYRIMIDINES (PAGE 3-105) > ADD > Q_ ROXANE LABORATORIES BOMGIISML! SUSPENSION; ORAL TABLET. CONTROLLED RELEASE; ORAL >_OLI_> lfRiSéI THEOCONTIN >_QLI_>/é§/ > ADD > BC PURDUE FREDERICK 2OOMG! > OLT > /—7BEE%H§gf£AB$/B££¢HAH/éééfiéléfié/TRISURE / THEO-DUR > OLT >léé/ r RVIDENIZIABS/léééfiéiéfii/ ) ADD > BC KEY PHARMACEUTICALS ZOOMG TABLET; ORAL > on > mme'sumau THIORIDAZINE HYDROCHLORIDE (PAGE 3-178) >;QLI_>/é§/ . .L TORIESSIAMO/

CONCENTRATE; ORAL THIORIDAZINE HCL TROPICAMIDE (PAGE 3-186) > ADD > A NATL PHARM MFG-BARRE IOOMGIML! SOLUTION-DROPS; OPHTHALMIC > ADD > HYDRIAFAIR > ADD > 91 PHARMAFAIR 0.52! > ADD > 91 999 , /EO'SO;OOO'UNITS'BASEI ULSEN/ ,,I >_QLI_>/éé/

/SOLVISTA > OLT > ORAL CAPSULE;

3-188) (PAGE PALMITATE A VITAMIN

> OLT >

lisbfip/ ' /¢5IIII¢/ Z EII 2

3-186) /fYBANAfE/(PASE > DLT >

'83 SEPTEMBER & '83 AUGUST / 1 NUMBER SUPPLEMENT CUMULATIVE / LIST PRODUCT DRUG ADDENDUM DESI PENDING LIST - 'EXEMPT' (COURT ORDER) CATEGORY CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '83

> > AN 9!; LOAT IRNEN'INISYIATII'CNEOIRIENIRA'I‘' ‘NALEAIEI'ISORROPANIOE/ >Ou>/ﬁc I Li'PNELYLRROPAIOEA IHL PVC m 0 L iDL](PAGE A03)

> DLT > /¢APSUL'EI.'IXINJ‘RIIJIEII.'PEIEASEI'PFAI/ -' >|_T>U /'T‘ S > DLT > I-IAgSI/IAJ‘IIRIESI /éfifléiéflGiéJSflGiSfiflfi/ > /so 'AANIJARLV' > m > /'1‘ -' > Ijéfikgfwfigfiilifififiifil HAWAII.iéNE/Sfliifiifi/SHLiiSNS/SNI/

DIPYRIDAMOLE (PAGE A04)

TABLET; ORAL DIPYRIDAMOLE > ADD > ASCOT HOSP PHARMS SOMG 1983-421—9272203OFFICE: PRINTING GOVERNMENT(1.5. ‘P

HYDROCHLORIDE PHENYLPROPANOLAMINE IODIDE; ISOPROPAMIDE > ADD >

MALEATE; CHLORPHENIRAMINE EDISYLATE; CARAMIPHEN > ADD >

LABORATORIES SK&F TUSS-ORNADE > ADD > > > > > III mm/mA-IEIAI/IF/RINEJ‘HINTIENE‘NALEAIE/'/ RRHISJ‘A > >

> 3H > l H .c ‘.‘PHAR.’“IIAIAIIIIAIAINF.IIIIAII/.' 'J‘N' I 3 ‘III .-" .v .-' ' .1‘ K

INEFFECTIVE - STATUS CURRENT

'83 SEPTEMBER & '83 AUGUST / 1 NUMBER SUPPLEMENT CUMULATIVE CATEGORY ORDER) (COURT 'EXEMPT' THAN OTHER - LIST PENDING DESI $ @ FOREIGN $83.75 $ O DOMESTIC $67.00

Supplements.

Cumulative monthly and List Products Drug Prescription Approved the

includes Subscription 1983. October, The in published be will Edition 4th

DESCRIPTION PRICE TOTAL PRICE UNIT QUANTITY

SIGNATURE AUTHORIZING DATE: OT [ to payable check (Make ] Documents) Superintendent [ ST for enclosed Check ] [ Number Order Purchase ] my No. Account GPO Charge

PAYMENT OF METHOD

CONTACT: Code) Area (Include TELEPHONE

purchaser) than different (If PURCHASER: TO: SHIP

783-3238 (202)

20402 DC Washington, Office Printing Government Documents of Superintendent

TO: MAIL DATE:

(1983) EDITION 4TH EVALUATIONS EQUIVALENCE THERAPEUTIC WITH APPROVED PRODUCTS DRUG PRESCRIPTION

FORM SUBSCRIPTION

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