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Product-Specifc Guidances for Generic Drug Development

Active Ingredient (link to Specifc URL Type Route RLD or RS Date Guidance) Number Recommended Acetaminophen; Benzhydrocodone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral 208653 11/2019 Hydrochloride PSG_208653.pdf Betamethasone Dipropionate; https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Aerosol, Foam 207589 11/2019 Calcipotriene PSG_207589.pdf Cefaclor https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet, Extended 050673 11/2019 PSG_050673.pdf Release Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 011300 11/2019 PSG_011300.pdf Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 500 mg 011529 11/2019 PSG_011529_Tab_500MG.pdf https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Intrauterine Intrauterine Device 018680 11/2019 PSG_018680.pdf Dolutegravir Sodium; Rilpivirine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 210192 11/2019 Hydrochloride PSG_210192.pdf Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 209844 11/2019 PSG_209844.pdf Encorafenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral 210496 11/2019 PSG_210496.pdf Indocyanine Green https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Intravenous, 211580 11/2019 PSG_211580.pdf Interstitial Isoniazid; Pyrazinamide; Rifampin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 050705 11/2019 PSG_050705.pdf Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule, Extended 019790 11/2019 PSG_019790.pdf Release Latanoprost; Netarsudil Dimesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Ophthalmic /Drops 208259 11/2019 PSG_208259.pdf Lidocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Patch 207962 11/2019 PSG_207962.pdf Lorlatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 210868 11/2019 PSG_210868.pdf Lutetium Dotatate Lu 177 https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Intravenous Solution 208700 11/2019 PSG_208700.pdf Active Ingredient (link to Specifc URL Type Route Dosage Form RLD or RS Date Guidance) Number Recommended Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 011839 11/2019 PSG_011839.pdf Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet, Orally 211210 11/2019 PSG_211210.pdf Disintegrating https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 202107 11/2019 PSG_202107.pdf Migalastat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 208623 11/2019 PSG_208623.pdf Omadacycline Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 209816 11/2019 PSG_209816.pdf Omadacycline Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Intravenous Powder 209817 11/2019 PSG_209817.pdf Oxymetazoline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical 208552 11/2019 PSG_208522.pdf Pimavanserin Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 210793 11/2019 PSG_210793.pdf Sumatriptan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Subcutaneous Injectable 020080 11/2019 PSG_020080.pdf Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Ophthalmic Solution 208135 11/2019 PSG_208135.pdf Timolol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Ophthalmic Solution, Forming/ 020330 11/2019 PSG_020330.pdf Drops Product-Specifc Guidances for Generic Drug Development

Active Ingredient (link to URL Type Route Dosage Form RLD or RS Number Date Specifc Guidance) Recommended Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical 022502 11/2019 PSG_022502.pdf Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Cream 020748 11/2019 PSG_020748.pdf Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 020380 11/2019 PSG_020380.pdf Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 021753 11/2019 PSG_021753.pdf Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 022320 11/2019 PSG_022320.pdf Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 207917 11/2019 PSG_207917.pdf Azacitidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Intravenous, Powder 050794 11/2019 PSG_050794.pdf Subcutaneous Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet, Orally 021589 11/2019 PSG_021589.pdf Disintegrating Benzoyl Peroxide; Clindamycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050819 11/2019 Phosphate PSG_050819.pdf Benzoyl Peroxide; Clindamycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050741 11/2019 Phosphate PSG_050741.pdf Benzoyl Peroxide; Clindamycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050756 11/2019 Phosphate PSG_050756.pdf Benzoyl Peroxide; Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050557 11/2019 PSG_050557.pdf Benzoyl Peroxide; Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050769 11/2019 PSG_050769.pdf Capsaicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Patch 022395 11/2019 PSG_022395.pdf Cariprazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 204370 11/2019 PSG_204370.pdf Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 750 mg 011529 11/2019 PSG_011529-Tab-750MG.pdf Active Ingredient (link to URL Type Route Dosage Form RLD or RS Number Date Specifc Guidance) Recommended Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050615 11/2019 PSG_050615.pdf Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050782 11/2019 PSG_050782.pdf Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Lotion 050600 11/2019 PSG_050600.pdf Clindamycin Phosphate; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 050802 11/2019 PSG_050802.pdf 050803 Clonidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Film, Extended Release 018891 11/2019 PSG_018891.pdf Clonidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 017407 11/2019 PSG_017407.pdf Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 207154 11/2019 PSG_207154.pdf Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 021794 11/2019 PSG_021794.pdf Diclofenac Epolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Patch 021234 11/2019 PSG_021234.pdf Didanosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule, Delayed 021183 11/2019 PSG_021183.pdf Release Pellets Disopyramide Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 017447 11/2019 PSG_017447.pdf Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Cream 020126 11/2019 PSG_020126.pdf https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Gel 022038 11/2019 PSG_022038.pdf Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 203752 11/2019 PSG_203752.pdf Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 019081 11/2019 PSG_019081.pdf Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 020375 11/2019 PSG_020375.pdf 021674 Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 020538 11/2019 PSG_020538.pdf Estradiol; https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 021258 11/2019 PSG_021258.pdf Active Ingredient (link to URL Type Route Dosage Form RLD or RS Number Date Specifc Guidance) Recommended Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 020870 11/2019 PSG_020870.pdf Ethinyl Estradiol; https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 200910 11/2019 PSG_021180.pdf 021180 Fentanyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 019813 11/2019 PSG_019813.pdf Flavoxate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 016769 11/2019 PSG_016769.pdf Granisetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 022198 11/2019 PSG_022198.pdf Indapamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 018538 11/2019 PSG_018538.pdf Lidocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Patch 020612 11/2019 PSG_020612.pdf Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 017812 11/2019 PSG_017812.pdf Menthol; Methyl Salicylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Patch 022029 11/2019 PSG_022029.pdf Metformin Hydrochloride; https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 022386 11/2019 Repaglinide PSG_022386.pdf Methylphenidate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 021514 11/2019 PSG_021514.pdf Mifepristone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 020687 11/2019 PSG_020687.pdf Molindone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 017111 11/2019 PSG_017111.pdf Mycophenolate Mofetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral 050759 11/2019 PSG_050759.pdf Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 020076 11/2019 PSG_020076.pdf 020165 Nitrofurantoin Macrocrystalline https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 016620 11/2019 PSG_016620.pdf Nitrofurantoin; Nitrofurantoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 020064 11/2019 Macrocrystalline PSG_020064.pdf Nitroglycerin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 020145 11/2019 PSG_020145.pdf Active Ingredient (link to URL Type Route Dosage Form RLD or RS Number Date Specifc Guidance) Recommended Nitroglycerin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 020144 11/2019 PSG_020144.pdf Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 202211 11/2019 PSG_202211.pdf Oxybutynin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 021351 11/2019 PSG_021351.pdf Pimecrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Cream 021302 11/2019 PSG_021302.pdf Prednisolone Sodium Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet, Orally 021959 11/2019 PSG_021959.pdf Disintegrating Rivastigmine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 022083 11/2019 PSG_022083.pdf Rofumilast https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 022522 11/2019 PSG_022522.pdf Rotigotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 021829 11/2019 PSG_021829.pdf Scopolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 017874 11/2019 PSG_017874.pdf Selegiline https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 021336 11/2019 PSG_021336.pdf Sulfacetamide Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Lotion 019931 11/2019 PSG_019931.pdf Sulfadiazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 040091 11/2019 PSG_004122.pdf Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Aerosol, Foam 202428 11/2019 PSG_202428.pdf Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 0.1% 020600 11/2019 PSG_020600-Gel-0.1P.pdf Terazosin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Capsule 020347 11/2019 PSG_020347.pdf Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Transdermal Film, Extended Release 020489 11/2019 PSG_020489.pdf Tinidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 021618 11/2019 PSG_021618.pdf Tipiracil Hydrochloride; Trifuridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Oral Tablet 207981 11/2019 PSG_207981.pdf Active Ingredient (link to URL Type Route Dosage Form RLD or RS Number Date Specifc Guidance) Recommended Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 0.1% 020475 11/2019 PSG_020475-Gel-0.1P.pdf Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 0.04% 020475 11/2019 PSG_020475-Gel-0.04P.pdf Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Cream 017340 11/2019 PSG_017340.pdf Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Cream 017522 11/2019 PSG_017522.pdf Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Cream 019049 11/2019 PSG_019049.pdf Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 017579 11/2019 PSG_017579.pdf Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 017955 11/2019 PSG_017955.pdf Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/ Draft Topical Gel 022070 11/2019 PSG_022070.pdf