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Orange Book October 2020 Changes List

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Orange Book October 2020 Changes List Prescription and Over-the-Counter Drug Product List 40TH EDITION Cumulative Supplement Number 10 : October 2020 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN SOLUTION;INTRAVENOUS ACETAMINOPHEN >A> AP AUROBINDO PHARMA LTD 1GM/100ML (10MG/ML) A 210969 001 Oct 21, 2020 Oct NEWA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE >D> AA SPECGX LLC 300MG;30MG A 040419 002 May 31, 2001 Oct CHRS >A> AA ! 300MG;30MG A 040419 002 May 31, 2001 Oct CHRS >D> TYLENOL W/ CODEINE NO. 3 >D> AA ! JANSSEN PHARMS 300MG;30MG A 085055 003 Aug 01, 1977 Oct DISC >A> @ 300MG;30MG A 085055 003 Aug 01, 1977 Oct DISC >D> TYLENOL W/ CODEINE NO. 4 >D> AA JANSSEN PHARMS 300MG;60MG A 085055 004 Aug 01, 1977 Oct DISC >A> @ 300MG;60MG A 085055 004 Aug 01, 1977 Oct DISC ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL OXYCODONE AND ACETAMINOPHEN >D> AA LANNETT CO INC 325MG;5MG A 207333 001 Sep 25, 2017 Oct DISC >A> @ 325MG;5MG A 207333 001 Sep 25, 2017 Oct DISC >D> AA 325MG;10MG A 207333 002 Sep 25, 2017 Oct DISC >A> @ 325MG;10MG A 207333 002 Sep 25, 2017 Oct DISC >D> AA NOSTRUM LABS INC 325MG;5MG A 209385 001 Jul 02, 2018 Oct DISC >A> @ 325MG;5MG A 209385 001 Jul 02, 2018 Oct DISC >D> AA 325MG;7.5MG A 209385 002 Jul 02, 2018 Oct DISC >A> @ 325MG;7.5MG A 209385 002 Jul 02, 2018 Oct DISC >D> AA 325MG;10MG A 209385 003 Jul 02, 2018 Oct DISC >A> @ 325MG;10MG A 209385 003 Jul 02, 2018 Oct DISC ACYCLOVIR CREAM;TOPICAL ACYCLOVIR >A> AB AMNEAL 5% A 208766 001 Nov 09, 2020 Oct NEWA AIR POLYMER-TYPE A FOAM;INTRAUTERINE EXEM FOAM KIT >D> + @ GISKIT 10ML N 212279 001 Nov 07, 2019 Oct CMFD >A> +! 10ML N 212279 001 Nov 07, 2019 Oct CMFD ALBUTEROL SULFATE SOLUTION;INHALATION ALBUTEROL SULFATE >D> AN AUROBINDO PHARMA LTD EQ 0.021% BASE A 211888 001 Apr 20, 2020 Oct DISC >A> @ EQ 0.021% BASE A 211888 001 Apr 20, 2020 Oct DISC >D> AN EQ 0.042% BASE A 211888 002 Apr 20, 2020 Oct DISC >A> @ EQ 0.042% BASE A 211888 002 Apr 20, 2020 Oct DISC TABLET;ORAL ALBUTEROL SULFATE >A> AB EYWA EQ 2MG BASE A 213524 001 Oct 08, 2020 Oct NEWA >A> AB EQ 4MG BASE A 213524 002 Oct 08, 2020 Oct NEWA >A> AB ZYDUS PHARMS EQ 2MG BASE A 208884 001 Oct 22, 2020 Oct NEWA >A> AB EQ 4MG BASE A 208884 002 Oct 22, 2020 Oct NEWA ALPRAZOLAM TABLET;ORAL ALPRAZOLAM >D> @ DAVA INTL INC 0.25MG A 074174 001 Oct 19, 1993 Oct CAHN >D> @ 0.5MG A 074174 002 Oct 19, 1993 Oct CAHN >D> @ 1MG A 074174 003 Oct 19, 1993 Oct CAHN >D> @ 2MG A 074174 004 Oct 19, 1993 Oct CAHN >A> @ NOVITIUM PHARMA 0.25MG A 074174 001 Oct 19, 1993 Oct CAHN >A> @ 0.5MG A 074174 002 Oct 19, 1993 Oct CAHN >A> @ 1MG A 074174 003 Oct 19, 1993 Oct CAHN Page 1 of 28 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALPRAZOLAM TABLET;ORAL ALPRAZOLAM >A> @ 2MG A 074174 004 Oct 19, 1993 Oct CAHN AMANTADINE HYDROCHLORIDE TABLET;ORAL AMANTADINE HYDROCHLORIDE >A> AB ALEMBIC PHARMS LTD 100MG A 214284 001 Oct 15, 2020 Oct NEWA AMINOCAPROIC ACID TABLET;ORAL AMINOCAPROIC ACID >A> AB MSN 500MG A 212938 001 Nov 06, 2020 Oct NEWA AMIODARONE HYDROCHLORIDE TABLET;ORAL PACERONE >A> AB UPSHER SMITH LABS 400MG A 075135 003 Jul 02, 2020 Oct NEWA AMLODIPINE BESYLATE; TELMISARTAN TABLET;ORAL TELMISARTAN AND AMLODIPINE >D> AB ALEMBIC PHARMS LTD EQ 5MG BASE;40MG A 205234 001 Nov 17, 2016 Oct DISC >A> @ EQ 5MG BASE;40MG A 205234 001 Nov 17, 2016 Oct DISC >D> AB EQ 5MG BASE;80MG A 205234 003 Nov 17, 2016 Oct DISC >A> @ EQ 5MG BASE;80MG A 205234 003 Nov 17, 2016 Oct DISC >D> AB EQ 10MG BASE;40MG A 205234 002 Nov 17, 2016 Oct DISC >A> @ EQ 10MG BASE;40MG A 205234 002 Nov 17, 2016 Oct DISC >D> AB EQ 10MG BASE;80MG A 205234 004 Nov 17, 2016 Oct DISC >A> @ EQ 10MG BASE;80MG A 205234 004 Nov 17, 2016 Oct DISC AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE >D> AB BIONPHARMA INC 1.25MG;1.25MG;1.25MG;1.25MG A 210293 001 Apr 03, 2020 Oct CAHN >D> AB 1.875MG;1.875MG;1.875MG;1.875MG A 210293 002 Apr 03, 2020 Oct CAHN >D> AB 2.5MG;2.5MG;2.5MG;2.5MG A 210293 003 Apr 03, 2020 Oct CAHN >D> AB 3.75MG;3.75MG;3.75MG;3.75MG A 210293 004 Apr 03, 2020 Oct CAHN >D> AB 5MG;5MG;5MG;5MG A 210293 005 Apr 03, 2020 Oct CAHN >D> AB 7.5MG;7.5MG;7.5MG;7.5MG A 210293 006 Apr 03, 2020 Oct CAHN >A> AB USPHARMA 1.25MG;1.25MG;1.25MG;1.25MG A 210293 001 Apr 03, 2020 Oct CAHN >A> AB 1.875MG;1.875MG;1.875MG;1.875MG A 210293 002 Apr 03, 2020 Oct CAHN >A> AB 2.5MG;2.5MG;2.5MG;2.5MG A 210293 003 Apr 03, 2020 Oct CAHN >A> AB 3.75MG;3.75MG;3.75MG;3.75MG A 210293 004 Apr 03, 2020 Oct CAHN >A> AB 5MG;5MG;5MG;5MG A 210293 005 Apr 03, 2020 Oct CAHN >A> AB 7.5MG;7.5MG;7.5MG;7.5MG A 210293 006 Apr 03, 2020 Oct CAHN AMPHETAMINE SULFATE TABLET;ORAL AMPHETAMINE SULFATE >A> AA ALKEM LABS LTD 5MG A 213720 001 Oct 27, 2020 Oct NEWA >A> AA 10MG A 213720 002 Oct 27, 2020 Oct NEWA >A> AA EPIC PHARMA LLC 5MG A 213980 001 Oct 27, 2020 Oct NEWA >A> AA 10MG A 213980 002 Oct 27, 2020 Oct NEWA AMPICILLIN/AMPICILLIN TRIHYDRATE CAPSULE;ORAL AMPICILLIN TRIHYDRATE >D> SANDOZ EQ 250MG BASE A 064082 001 Aug 29, 1995 Oct DISC >A> @ EQ 250MG BASE A 064082 001 Aug 29, 1995 Oct DISC APREPITANT CAPSULE;ORAL APREPITANT >A> AB TORRENT 40MG A 211835 001 Oct 21, 2020 Oct NEWA >A> AB 80MG A 211835 002 Oct 21, 2020 Oct NEWA >A> AB 125MG A 211835 003 Oct 21, 2020 Oct NEWA Page 2 of 28 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST >D> ASPIRIN; OMEPRAZOLE >D> TABLET, DELAYED RELEASE;ORAL >D> YOSPRALA >D> + GENUS LIFESCIENCES 81MG;40MG N 205103 001 Sep 14, 2016 Oct DISC >A> + @ 81MG;40MG N 205103 001 Sep 14, 2016 Oct DISC >D> +! 325MG;40MG N 205103 002 Sep 14, 2016 Oct DISC >A> + @ 325MG;40MG N 205103 002 Sep 14, 2016 Oct DISC ATENOLOL TABLET;ORAL ATENOLOL >D> AB DAVA PHARMS INC 50MG A 073542 001 Dec 19, 1991 Oct DISC >A> @ 50MG A 073542 001 Dec 19, 1991 Oct DISC >D> AB 100MG A 073543 001 Dec 19, 1991 Oct DISC >A> @ 100MG A 073543 001 Dec 19, 1991 Oct DISC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE >A> AA ECI PHARMS LLC 0.025MG;2.5MG A 207128 001 Oct 21, 2020 Oct NEWA >A> AA SPECGX LLC 0.025MG;2.5MG A 213335 001 Oct 06, 2020 Oct CPOT >D> AA 2.5MG;0.025MG A 213335 001 Oct 06, 2020 Oct CPOT AZACITIDINE POWDER;INTRAVENOUS, SUBCUTANEOUS AZACITIDINE >A> AP NANJING KING-FRIEND 100MG/VIAL A 212128 001 Nov 02, 2020 Oct NEWA AZITHROMYCIN TABLET;ORAL AZITHROMYCIN >D> AB ALEMBIC PHARMS LTD EQ 600MG BASE A 211793 001 Jan 27, 2020 Oct DISC >A> @ EQ 600MG BASE A 211793 001 Jan 27, 2020 Oct DISC BACLOFEN TABLET;ORAL BACLOFEN >A> AB INNOGENIX 10MG A 212378 001 Oct 09, 2020 Oct NEWA >A> AB 20MG A 212378 002 Oct 09, 2020 Oct NEWA BETHANECHOL CHLORIDE TABLET;ORAL BETHANECHOL CHLORIDE >D> AA WOCKHARDT 10MG A 040533 001 Sep 29, 2003 Oct DISC >A> @ 10MG A 040533 001 Sep 29, 2003 Oct DISC >D> AA 25MG A 040534 001 Sep 29, 2003 Oct DISC >A> @ 25MG A 040534 001 Sep 29, 2003 Oct DISC BOSENTAN TABLET;ORAL BOSENTAN >D> AB ALEMBIC PHARMS LTD 62.5MG A 211461 001 Jan 23, 2020 Oct DISC >A> @ 62.5MG A 211461 001 Jan 23, 2020 Oct DISC >D> AB 125MG A 211461 002 Jan 23, 2020 Oct DISC >A> @ 125MG A 211461 002 Jan 23, 2020 Oct DISC BROMFENAC SODIUM SOLUTION/DROPS;OPHTHALMIC BROMFENAC SODIUM >D> AT2 MYLAN EQ 0.09% ACID A 203368 001 Jun 03, 2019 Oct DISC >A> @ EQ 0.09% ACID A 203368 001 Jun 03, 2019 Oct DISC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP;ORAL BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE >A> AA RHODES PHARMS 2MG/5ML;10MG/5ML;30MG/5ML A 202955 001 Nov 05, 2020 Oct NEWA Page 3 of 28 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST >D> BUPRENORPHINE HYDROCHLORIDE >D> IMPLANT;IMPLANTATION >D> PROBUPHINE >D> +! TITAN PHARMS EQ 80MG BASE/IMPLANT N 204442 001 May 26, 2016 Oct DISC >A> + @ EQ 80MG BASE/IMPLANT N 204442 001 May 26, 2016 Oct DISC BUSULFAN INJECTABLE;INJECTION BUSULFAN >A> AP NANJING KING-FRIEND 6MG/ML A 212127 001 Oct 23, 2020 Oct NEWA CABERGOLINE TABLET;ORAL CABERGOLINE >D> AB INGENUS PHARMS LLC 0.5MG A 204735 001 Aug 01, 2018 Oct CHRS >A> AB ! 0.5MG A 204735 001 Aug 01, 2018 Oct CHRS >D> AB ! PAR PHARM 0.5MG A 076310 001 Dec 29, 2005 Oct DISC >A> @ 0.5MG A 076310 001 Dec 29, 2005 Oct DISC CARISOPRODOL TABLET;ORAL CARISOPRODOL >D> @ FOSUN PHARMA 350MG A 081025 001 Apr 13, 1989 Oct CMFD >A> AA 350MG A 081025 001 Apr 13, 1989 Oct CMFD CARMUSTINE INJECTABLE;INJECTION CARMUSTINE >A> AP DR REDDYS 100MG/VIAL A 213207 001 Oct 22, 2020 Oct NEWA CEFOTETAN DISODIUM INJECTABLE;INJECTION CEFOTAN >D> AP + TELIGENT EQ 1GM BASE/VIAL N 050588 001 Dec 27, 1985 Oct CAHN >A> AP + EQ 1GM BASE/VIAL N 050588 001 Dec 27, 1985 Oct CAHN >D> AP + EQ 2GM BASE/VIAL N 050588 002 Dec 27, 1985 Oct CAHN >A> AP + EQ 2GM BASE/VIAL N 050588 002 Dec 27, 1985 Oct CAHN >D> @ EQ 10GM BASE/VIAL N 050588 003 Apr 25, 1988 Oct CAHN >A> @ EQ 10GM BASE/VIAL N 050588 003 Apr 25, 1988 Oct CAHN CEFOTAN IN PLASTIC CONTAINER >D> @ TELIGENT EQ 20MG BASE/ML N 050694 002 Jul 30, 1993 Oct CAHN >A> @ EQ 20MG BASE/ML N 050694 002 Jul 30, 1993 Oct CAHN >D> @ EQ 40MG BASE/ML N 050694 001 Jul 30, 1993 Oct CAHN >A> @ EQ 40MG BASE/ML N 050694 001 Jul 30, 1993 Oct CAHN CEFTAZIDIME INJECTABLE;INJECTION CEFTAZIDIME >D> AP WOCKHARDT 1GM/VIAL A 065196 001 Oct 15, 2008 Oct DISC >A> @ 1GM/VIAL A 065196 001 Oct 15, 2008 Oct DISC CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE >A> AB ECI PHARMS LLC 5MG;2.5MG A 213530 001 Oct 20, 2020 Oct NEWA CHLORPROMAZINE HYDROCHLORIDE TABLET;ORAL CHLORPROMAZINE HYDROCHLORIDE >A>
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