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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST42DIATRIZOATE SODIUMINJECTABLE; INJECTIONHYPAQUEWINTHROP LISTER LING 257. * 507.POWDER FOR RECONSTITUTION; ORAL, RECTALHYPAQUEWINTHROP LISTER LING 250MG/CANSOLUTION; ORAL, RECTALHYPAQUEWINTHROP LISTER LING 407.SOLUTION; URETERALHYPAQUEWINTHROP LISTER LING 207.DIBUCAINE HYDROCHLORIDEINJECTABLE; INJECTIONNUPERCAINECIBA PHARMDICHLORPHENAMIDE5MG/2MLTABLET; ORA~DARAHJ:DEA8 MERCK SHARP & DOHME SONGORATROLBP ALCON LABS SOMGDICLOXICILLIN SODIUM MONOHYDRATECAPSULE; ORALDIATRIZOATE SODIUM; *NULTIPLE*DYCJ:LLSEE DIATRIZOATE MEGLUMINEj DIATRIZOATE SODIUM A8 BEECHAM LABS EQ 2S0NG BASE M EQ SOONG 8ASEDYHAPEHA8 BRISTOL LABS/BM EQ 2S0NG 8ASEDIAZEPAMEQ 12SMG BASEPATHOCJ:LINJECTABLE; INJECTIONA8 WYETH LABS/AMHO EQ 2S0MG 8ASEVALIUMVERACJ:LLJ:HHOFFMANN-LA ROCHE 5MG/MLA8 AYERST LABS/AMHO EQ 2S0MG 8ASE M Eq SOOMG 8ASETABLET; ORALVALIUMHOFFMANN-LA ROCHEDIAZOXl;DECAPSULE; ORALPROGLYCEMSCHERINGINJECTABLE; INJECTIONHYPERSTATSCHERINGSUSPENSION; ORALPROGLYCEMSCHERING2MG * SMG * 10MG50MG * 100MGISMGINLSOMGINLPOWDER FOR RECONSTITUTION; ORALDYHAPEHA8 BRISTOL LABS/BM Eq 62.SMG 8ASE/SMLPATHOCILA8 WYETH LABS/ANHO EQ 62.SMG BASE/SMLDIENESTROLCREAM; VAGINALDIEHESTROLAT ORTHO PHARM O.Ol?DVAT MERRELL-NATIONAL ~ESTRAGUARDAT REID-PROVIDENT LABS ~SUPPOSITORY; VAGINALDVMERRELL-NATIONAL700 UGM
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST43AAAAAAAAAADIETHYLCARBAMAZINE CITRATETABLET; ORALHETRAZANLEDERLE LABS/AM CYAN 50MGDIETHYLPROPION HYDROCHLORIDETABLET; ORALDIETHYLPROPIOH HCLCHELSEA LABS25MBLEMMON PHARMACAL 25MBMD PHARM 25MBTEHUATEHERRELL-NATIONALTEPAHILRIKER LABS/3M25MB25MBTABLET, CONTROLLED RELEASE; ORALTENUATEBC MERRELL-NATIONAL 75MGTEPANIL TEN-TABBC RIKER LABS/3M 75MGDIETHYLSTILBESTROLINJECTABLE; INJECTIONSTILBESTROLER SQUIBB AND SONS 200 UGM/ML * 500 UGM/ML * IMG/ML *5MG/MLDIETHYLSTILBESTROLTABLET, ENTERIC COATED; ORALDIETHYLSTILBESTROLBE ELI LILLY 100 UGM * 500 UGM * IMG * 5MG250 UGMBE ICN PHARMS 5MGSTILBESTROLBE ER SQUIBB AND SONS 100 UGM * 500 UGM * IMG * 5MGBE TABLICAPS 500 UGM * IMG * 5MGDIETHYLSTILBESTROL DIPHOSPHATEINJECTABLE; INJECTIONSTILPHOSTROLDOME LABS/MILES LABS 250HG/5MLTABLET; ORALSTILPHOSTROLDOME LABS/MILES LABS 50MGDIETHYLSTILBESTROL; METHYLTESTOSTERONETABLET; ORALTYLOSTERONEELI LILLY250 UGM;5MGDIFENOXIN HYDROCHLORIDE; *MULTIPLE*SEE ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDEATATTABLET; ORALDIETHYLSTILBESTROLBP Ell LILLYBP WEST-WARDBPBPSUPPOSITORY; VAGINALDIETHYLSTILBESTROLEll LILLYSTILBESTROLER SQUIBB AND SONSSTILBESTROLER SQUIBB AND SONSTABLICAPS100 UGM * 500 UBM100 UGM * 500 UGM100 UGM * 500 UGM * IMGIMG100 UGM * 500 UGM * IMG * 5MG500 UGM * IMG * SMGDIFLORASONE DIACETATECREAM; TOPICALFLORONEUPJOHNOINTMENT; TOPICALFLORONEUPJOHN0.05/.O.OS/.'.'
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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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"~''''''-- .APPROVED PRESCRIPTION D
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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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