first edition (1980) of the Orange Book - FDA Law Blog

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST68HYDROCORTISONE ACETATEINJECTABLE; INJECTIONHYDROCORTISONE ACETATEBP CARTER-GLOGAU LABS 2SMG/ML * 50MG/MLBP D-M PHARMACEUTICALS 2SMG/ML * SOMG/MLBP MAURRY BIOLOGICAL 2SMG/ML * SOMG/MLHYDROCORTONEBP MERCK SHARP & DOHME 2SMG/ML * SOMG/MLATATLOTION; TOPICALDR:ICORTINGRAM PHARMHYDRCCC~T:ISOHE ACETATETOWNE PAULSENOINTMENT; OPHTHALMICHYDROCORTISONE ACETATEBYK-GULDENHYDROCORTONEMERCK SHARP & DOHME0.5?O.S?O.S7.lo57.HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDEAEROSOL; RECTALPROCTOFOAM HCREED & CARNRICK Ii:; Ii:CREAM; TOPICALPRAMOSONEFERNDALE LABSO. 5i:;Ii: * li:;Ii:LOTION; TOPICALPRAMOSONEFERNDALE LABSHYDROCORTISONE ACETATE; UREACREAM; TOPICALCARMOL HCSYNTEX LABS17.;lO7.O.5i:;Ii: * li:;I7. * 2.S7.;I7.ATATOINTMENT; TOPICALCCRTEF ACETATEUPJOHN 17.2.5i:HYDRCCORTCHEMERCK SHARP & DOHME . I?HYDROCORTISONE CYPIONATESUSPENSION; ORALCORTEFUPJOHNEQ lOMG BASE/SMLPASTE; TOPICALHYDROCORTISONE SODIUM PHOSPHATEORABASE HCAHOYT LABS/C-P O.5i:INJECTABLE; INJECTIONPOWDER; FOR RX COMPOUNDINGHYDROCORTONEMERCK SHARP & DOHME EQ SOMG BASE/MLHYDROCORTISONE ACETATEPHARM.4-TEK10GM/BOT * SOGM/BOTHYDROCORTISONE SODIUM SUCCINATESUSPENSION/DROPS; OPHTHALMICHYDROCORTONEINJECTABLE; INJECTIONMERCK SHARP & DOHME 2.5i:A-HYDROCORTAP ABBOTT LABSEQ 100MG BASE/2ML MAPEQ SOONG BASE/4ML MHYDROCORTISONE ACETATE; *MULTIPLE* AP E9 16M BASE/8NL M EQ 2S0MG BASE/2MLSEE COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCINSOLU-CORTEFSULfATE; THONZONIUM BROMIDEAP UPJOHNE9 100M6 BASE/2ML MAPE9 16M BASE/8ML MAPE9 2S0MG BASEI2ML MAPE9 SOOMG BASE/4ML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST69HYDROCORTISONE VALERATECREAM; TOPICALWESTCORTWESTWOOD PH ARMSO.2/'HYDROFLUMETHIAZIDETABLET; ORALSALURONAB BRISTOL LABS/BM SOMGHYDROCORTISONE; *MULTIPLE*SEE ACETIC ACID, GLACIAL; HYDROCORTISONESEE ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATEHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESOLUTION; OTICCORTISPORINBURROUGHS WELLCOMEIX;EQ 3.5MG BASEIML;IO,OOO UNITS/MLSUSPENSION; OTICCORTJ:SPORJ:HAT BURROUGHS WELLCOME l~;EQ !.5MG BASE/ML;lO.OOO UNJ:TS/MLOTOBJ:ONEAT SCHERING l~;EQ !.5MG BASE/ML;lO.OOO UNJ:TS/MLHYDROCORTISONE; POLYMYXIN B SULFATESOLUTION; OTICPYOCIDINBERLEX LABS/S-AGHYDROCORTISONE; UREACREAM; TOPICALALPHAOERMAT NORWICH-EATON PHARM l~;lO~CALMURJ:O HCAT PHARMACIA LABS l~;lO?HYDROFLUMETHIAZIDETABLET; ORALOJ:UCAROJ:HAB AYERST LABS/AMHO SOMG5MG/ML;IO,OOO UNITS/MLHYDROFLUMETHIAZIDE; RESERPINETABLET; ORALSALUTENSINBRISTOL LABS/BMSALUTENSIN-DEMIBRISTOL LABS/BMHYDROXOCOBALAMININJECTABLE; INJECTIONALPHA-RUVITEAP SAVAGE/BYK-GULDENALPHAREnISOLAP MERCK SHARP & DOHMEHYDROCOBALAMJ:HAP D-M PHARMACEUTICALSHYDROXOCOBALAMIHAP CARTER-GLOGAU LABSAP LYPHO-MED50MG;I25 UGM25MG;l25 UGMlMG/MLlMG/MLlMG/MLlMG/MLlMG/MLHYDROXY AMPHETAMINE HYDROBROMIDESOLUTION/DROPS; OPHTHALMICPAREDRINESKF LABSIXHYDROXYCHLOROQUINE SULFATETABLET; ORALPLAQUENILWINTHROP LISTER LINGHYDROXYPROGESTERONE CAPROATE200MGINJECTABLE; INJECTIONDELALUTIHAO ER SQUIBB AND SONS l25MG/ML M 250MG/ML
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RXD AND DRUG ACMINISTRATIONAPProVED
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approved application, a list of app
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products that have been approved" i
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To assist the user in relating the
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an evaluatien of therapeutic equiva
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ioavailability data is required for
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B - Drug products that FDA does not
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and the rate of absorption.pharmace
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4. Erythromycin stearate Tablets -
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II. LISTINGSA. FORMAT GUIDEThis p..
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CURRENT STATUS - POSSIBLY EFFECTIVE
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DRUG ProDUCT EKAMPLESSingle Ingredi
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APPROVED PRESCRIPTION DRUG PRODUCTS
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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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