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FDA Approval Activities for this Drug…
Colocort (Hydrocortisone Enema USP), /60 mL Paddock, 75-172 Cortifoam (hydrocortisone acetate rectal metered ), Schwartz Pharma, 17-351/S-027 Hydrocortisone Acetate Cream 2.5% Ferndale , 40-259 7/29/99 8/4/99 1/17/02 Hydrocortisone Lotion 2.5%, Vintage 40-417 7/30/03 Hydrocortisone Lotion 2.5%, Altana, 40-351 7/25/00 10/30/00 Hydrocortisone Lotion 2.5%, Thames Pharmcal 40-247 7/23/99 8/6/99 Hydrocortisone Valerate Cream , Clay-Park Labs, 75-666 5/24/00 5/31/00 Hydrocortisone Valerate Cream , Copley Pharmaceutical 74-489 8/12/98 8/14/98 8/24/01 Hydrocortisone Valerate Cream , Taro USA 75-042 8/25/98 8/28/98 8/6/03 Hydrocortisone Valerate Ointment , Taro USA 75-043 8/25/98 8/28/98 8/24/01 Hydrocortisone Valerate Ointment , Altana 75-085 7/31/01 Hydrocortisone Valerate Ointment 2.5%, Thames Pharmacal Co., 40-310 Micort-HC Lipocream (Hydrocortisone Acetate Cream USP), 2%, Ferndale , 40-398 3/29/02 4/8/03 Micort-HC Lipocream (Hydrocortisone Acetate Cream USP), 2.5%, Ferndale , 40-396 Westcort (hydrocortisone valerate) Cream, Bristol-Myers Squibb Pharmaceutical Research Institute 17-950/S021 3/24/03 3/25/03 3/25/03 Westcort (hydrocortisone valerate) Ointment, Bristol-Myers Squibb Pharmaceutical Research Institute 18-726/S9 & S12 ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% ACETASOL HC ALPHARMA 012770 AT ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% VOSOL HC MEDPOINTE HLC 040168 AT ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% HYDROCORTISONE AND ACETIC ACID Morton Grove 088759 AT ACETIC ACID, GLACIAL; HYDROCORTISONE 2%;1% HYDROCORTISONE AND ACETIC ACID Taro 064068 AT BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%; 3. BASE/GM; /GM NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE BAUSCH AND LOMB 050416 AT BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%; 3. BASE/GM; /GM CORTISPORIN MONARCH 050168 BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;1%; 3. BASE/GM;5,000 UNITS/GM CORTISPORIN MONARCH 062166 BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%; 3. BASE/GM; /GM BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE PHARMADERM 020805 CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE /Drops; 1% CIPRO HC Alcon 050356 COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE /Drops; ; 3. 0. COLY-MYCIN S PARKEDALE 088216 AT HYDROCORTISONE 1% PENECORT ALLERGAN HERBERT 089682 AT HYDROCORTISONE 2.5% HYDROCORTISONE ALPHARMA 087795 AT HYDROCORTISONE 1% HYDROCORTISONE ALPHARMA US 080848 AT HYDROCORTISONE 0.5% HYDROCORTISONE Altana 080848 AT HYDROCORTISONE 1% HYDROCORTISONE Altana 080483 AT HYDROCORTISONE 2.5% HI-COR C AND M 085025 AT HYDROCORTISONE 2.5% HYDROCORTISONE Clay Park 080706 AT HYDROCORTISONE 1% ALA-CORT DEL RAY 080472 AT HYDROCORTISONE 1% HYTONE DERMIK 080472 AT HYDROCORTISONE 2.5% HYTONE DERMIK 080452 AT HYDROCORTISONE 1% HYDROCORTISONE EVERYLIFE 080693 AT HYDROCORTISONE 1% HYDROCORTISONE FOUGERA 089414 AT HYDROCORTISONE 2.5% HYDROCORTISONE FOUGERA 080456 AT HYDROCORTISONE 0.5% HYDROCORTISONE INGRAM 080456 AT HYDROCORTISONE 1% HYDROCORTISONE INGRAM 087458 AT HYDROCORTISONE 1% SYNACORT MEDICIS 087457 AT HYDROCORTISONE 2.5% SYNACORT MEDICIS 088250 AT HYDROCORTISONE 2.5% ANUSOL HC PARKEDALE 089413 AT HYDROCORTISONE 2.5% HYDROCORTISONE PHARMADERM 085527 AT HYDROCORTISONE 0.5% HYDROCORTISONE SYOSSET 086155 AT HYDROCORTISONE 1% HYDROCORTISONE Taro 088799 AT HYDROCORTISONE 2.5% HYDROCORTISONE Taro 074171 HYDROCORTISONE Enema; Rectal /60ML HYDROCORTISONE Copley 075172 HYDROCORTISONE Enema; Rectal /60ML COLOCORT Paddock 016199 HYDROCORTISONE Enema; Rectal /60ML CORTENEMA SOLVAY 040351 AT HYDROCORTISONE Lotion; 2.5% HYDROCORTISONE Altana 083219 AT HYDROCORTISONE Lotion; 0.5% EPICORT BLULINE 083201 AT HYDROCORTISONE Lotion; 1% ALA-CORT DEL RAY 083231 HYDROCORTISONE Lotion; 2% ALA-SCALP DEL RAY 080473 AT HYDROCORTISONE Lotion; 1% HYTONE DERMIK 080473 AT HYDROCORTISONE Lotion; 2.5% HYTONE DERMIK 080426 AT HYDROCORTISONE Lotion; 0.5% CETACORT HEALTHPOINT 080443 AT HYDROCORTISONE Lotion; 1% NUTRACORT HEALTHPOINT 080426 AT HYDROCORTISONE Lotion; 1% CETACORT HEALTHPOINT 087644 AT HYDROCORTISONE Lotion; 2.5% NUTRACORT HEALTHPOINT 089066 AT HYDROCORTISONE Lotion; 1% STIE-CORT STIEFEL 089074 AT HYDROCORTISONE Lotion; 2.5% STIE-CORT STIEFEL 040247 AT HYDROCORTISONE Lotion; 2.5% HYDROCORTISONE Taro 040417 AT HYDROCORTISONE Lotion; 2.5% HYDROCORTISONE Vintage 087796 AT HYDROCORTISONE 1% HYDROCORTISONE ALPHARMA US 080489 AT HYDROCORTISONE 1% HYDROCORTISONE Altana 080692 AT HYDROCORTISONE 1% HYDROCORTISONE Altana 088138 AT HYDROCORTISONE 1% HYDROCORTISONE IN ABSORBASE CAROLINA MEDCL 085027 AT HYDROCORTISONE 2.5% HYDROCORTISONE Clay Park 081203 AT HYDROCORTISONE 2.5% HYDROCORTISONE FOUGERA 009176 AT HYDROCORTISONE 1% CORTRIL PFIPHARMECS 009176 AT HYDROCORTISONE 2.5% CORTRIL PFIPHARMECS 086257 AT HYDROCORTISONE 1% HYDROCORTISONE Taro 040310 AT HYDROCORTISONE 2.5% HYDROCORTISONE Taro 088082 HYDROCORTISONE Powder; For Compounding 100% HYDROCORTISONE Paddock 085982 HYDROCORTISONE Powder; For Compounding 100% HYDROCORTISONE TEK 088214 AT HYDROCORTISONE Solution; 1% PENECORT ALLERGAN HERBERT 080425 AT HYDROCORTISONE Solution; 1% TEXACORT SIRIUS 081271 HYDROCORTISONE Solution; 2.5% TEXACORT SIRIUS 008506 BP HYDROCORTISONE HYDROCORTONE MERCK 008506 BP HYDROCORTISONE HYDROCORTONE MERCK 008697 BP HYDROCORTISONE CORTEF PHARMACIA AND UPJOHN 008697 BP HYDROCORTISONE CORTEF PHARMACIA AND UPJOHN 008697 HYDROCORTISONE CORTEF PHARMACIA AND UPJOHN 083365 BP HYDROCORTISONE HYDROCORTISONE West Ward 017351 HYDROCORTISONE ACETATE , Metered; Rectal 10% CORTIFOAM SCHWARZ 040398 HYDROCORTISONE ACETATE 2% MICORT-HC FERNDALE 040396 HYDROCORTISONE ACETATE 2.5% MICORT-HC FERNDALE 040259 HYDROCORTISONE ACETATE 2.5% HYDROCORTISONE ACETATE FERNDALE 086207 HYDROCORTISONE ACETATE Lotion; 0.5% DRICORT INGRAM 080828 HYDROCORTISONE ACETATE Ointment; Ophthalmic 0.5% HYDROCORTISONE ACETATE Altana 083205 HYDROCORTISONE ACETATE Paste; 0.5% ORABASE HCA COLGATE 085981 HYDROCORTISONE ACETATE Powder; For Compounding 100% HYDROCORTISONE ACETATE TEK 050218 HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 0.5%; 3. BASE/GM; /GM CORTISPORIN MONARCH 061016 HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE /Drops; Ophthalmic 1.5%; BASE TERRA-CORTRIL PFIZER 089440 BX HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE , Metered; 1%;1% HYDROCORTISONE ACETATE 1% AND PRAMOXINE HCL 1% Copley 086195 BX HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE , Metered; 1%;1% PROCTOFOAM HC SCHWARZ 086457 BX HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE , Metered; 1%;1% EPIFOAM SCHWARZ 083778 HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 0.5%;1% PRAMOSONE FERNDALE 085368 HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 1%;1% PRAMOSONE FERNDALE 085980 HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE Lotion; 1%;1% PRAMOSONE FERNDALE 085979 HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE Lotion; 2.5%;1% PRAMOSONE FERNDALE 080505 AT HYDROCORTISONE ACETATE; UREA 1%;10% CARMOL HC KENWOOD 089472 AT HYDROCORTISONE ACETATE; UREA 1%;10% U-CORT Taro 020769 HYDROCORTISONE BUTYRATE 0.1% LOCOID LIPOCREAM FERNDALE 018514 HYDROCORTISONE BUTYRATE 0.1% LOCOID FERNDALE 018652 HYDROCORTISONE BUTYRATE 0.1% LOCOID FERNDALE 019116 HYDROCORTISONE BUTYRATE Solution; 0.1% LOCOID FERNDALE 020453 HYDROCORTISONE PROBUTATE 0.1% PANDEL SAVAGE 085929 HYDROCORTISONE SODIUM SUCCINATE A-HYDROCORT Abbott 085932 HYDROCORTISONE SODIUM SUCCINATE 1GM A-HYDROCORT Abbott 085930 HYDROCORTISONE SODIUM SUCCINATE A-HYDROCORT Abbott 085931 HYDROCORTISONE SODIUM SUCCINATE A-HYDROCORT Abbott 087532 HYDROCORTISONE SODIUM SUCCINATE HYDROCORTISONE SODIUM SUCCINATE INTL MEDICATION 009866 HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF PHARMACIA AND UPJOHN 009866 HYDROCORTISONE SODIUM SUCCINATE 1GM SOLU-CORTEF PHARMACIA AND UPJOHN 009866 HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF PHARMACIA AND UPJOHN 009866 HYDROCORTISONE SODIUM SUCCINATE SOLU-CORTEF PHARMACIA AND UPJOHN 075666 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE Clay Park 074489 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE Copley 075042 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE Taro 017950 HYDROCORTISONE VALERATE WESTCORT WESTWOOD SQUIBB 075085 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE Altana 075043 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE Taro 018726 HYDROCORTISONE VALERATE WESTCORT WESTWOOD SQUIBB 062423 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%; 3. NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Alcon 064053 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%; 3. NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE BAUSCH AND LOMB 050479 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%; 3. CORTISPORIN MONARCH 062874 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE /Drops; Ophthalmic 1%; 3. NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Alcon UNIVERSAL 050169 HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE /Drops; Ophthalmic 1%; 3. CORTISPORIN MONARCH 062488 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE /Drops; 1%; 3. NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Alcon UNIVERSAL 064065 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE /Drops; 1%; 3. AIR BAUSCH AND LOMB 062822 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE /Drops; 1%; 3. PEDI MONARCH 060613 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE /Drops; 1%; 3. CORTISPORIN MONARCH 062302 HYDROCORTISONE; POLYMYXIN B SULFATE ; BASE OTOBIOTIC SCHERING Cortisporin Ophthalmic King Cortifoam (hydrocortisone acetate) Rectal Foam, Schwartz Pharma Hydrocortisone Butyrate Topical Solution, Taro Hydrocortisone Cream USP, Vintage Pharmaceuticals Cortisporin Ophthalmic Ointment, Monarch Pharmaceuticals Locoid Lipocream (hydrocortisone butyrate cream) Cream, Ferndale Laboratories, Manufacturing Change or Addition | Hydrocortisone Butyrate Ointment, Taro Pharma, Approval | Hydrocortisone Butyrate Cream, Taro Pharma, Approval | Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, PharmaForce, Approval | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, PharmaForce, Approval | Locoid (hydrocortisone butyrate) Cream, Ferndale Labs, Control Supplement | Hydrocortisone and Acetic Otic Solution, Vintage Pharma, Approval | A-HydroCort (Hydrocortisone Sodium Succinate) Injection, Hospira, Approval | Locoid Lipocream (hydrocortisone butyrate) Cream, Ferndale Labs, Package Change | Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, PharmaForce, Approval | Hydrocortisone Tablets, Stiefel Labs, Approval | Locoid (Hydrocortisone Butyrate) Lotion, Ferndale Labs, Approval | Hydrocortisone Tablets, Vintage Pharma, Approval | CORTENEMA (hydrocortisone) Rectal Suspension, ANI Pharma, Labeling Revision
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