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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST84MESORIDAZINE BESYLATEMESTRANOL; NORETHYNODRELINJECTABLE; INJECTIONSERENTILSANDOZ PH ARMSEQ 2SMG BASE/MLTABLET; ORALENOVIDSEARLE7S UGM;5MG * ISO UGM;9.8SMGTABLET; ORALSERENTILSANDOZ PH ARMSEQ 10MG BASE * EQ 2SMG BASE *EQ SOMG BASE * EQ 100MG BASETABLET; ORAL-20ENOVIDSEARLEENOVID-ESEARLE7S UGM;SMG100 UGM;2.SMGMESTRANOL; *MULTIPLE*SEE ETHYNODIOL DIACETATE; MESTRANOLTABLET; ORAL-21ENOVID-E 21SEARLE100 UGM;2.SMGA8ABABABABABABAB.MESTRANOL; NORETHINDRONETABLET; ORAL-20NORINYLSYNTEX(F PITABLET; ORAL-21HORl:HYL 1+50 21SYNTEX(F PIHOR:IHYL 1+80 ZlSYNTEX(F PIORTHO-H~VUM 1/50 21ORTHO PHARMORTHO-HOVUM 1/80 21ORTHO PHARMORTHO-NOVUM 10-21ORTHO PHARMORTHO-NOVUM 2-21ORTHO PHARMTABLET; ORAL-28HOR:IHYL 1+50 28SYNTEX(F PIHOR:IHYL 1+80 28SYNTEX(F PIORTHO-HOVUM 1/50 28ORTHO PHARMORTHO-HOVUM 1/80 28ORTHO PHARM100 UGM;2MG~;lMG~;lMG50 UGM;lMG80 UGM;lMG60 UGM;lOMG100 UGM;2MG~;lMG~;lMGSO UGM;lMG~;lMGAPAPAPAPAPAPMETAPROTERENOL SULFATEAEROSOL; INHALATIONALUPENTBOEHRINGER INGELHEIM lSMG/MLSYRUP; ORALALUPENTBOEHRINGER INGELHEIM 10MG/SMLTABLET; ORALALUPENTBOEHRINGER INGELHEIM 10MG * 20MGMETARAMINOL BITARTRATEINJECTABLE; INJECTIONAR.AM:IHEMERCK SHARP & DOHMEMETARAM:IHOL B:ITARTRATEAM MCGAW/AM HOSP. BRISTOL LABS/BMELKINS-SINN/AHROBINSINT'L MEDICATION SYSINVENEX PHARMS/MOGULEQ 10MG BASE/MLEQ 100MG 8ASE/I0MLEQ 200MG BASE/I0MLEQ 10MG BASE/MLEQ 10MG BASE/MLEQ 10MG BASE/MLEQ lONG BASE/ML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST85METAXAlONETABLET; ORALSKElAXINAH ROBINSIMETHACYClINE HYDROCHLORIDECAPSULE; ORALRONDOMYCINWAllACE lABS/C-WSYRUP; ORALRONDOMYCINWAllACE LABS/C-WMETHADONE HYDROCHLORIDECONCENTRATE; ORALMETHADOSEMAllINCKRODTINJECTABLE; INJECTIONDOlOPHIN,E HClEll lILLYSYRUP; ORALDOLOPHrHE HCLAA ELI lILLYWESTADOHEAA VITARINE/WEST CHEMTABLET; ORALDOlOPHINE HClEll lILLYMETHADONE HClELI lILLY400"MGEQ 140NG BASE * EQ 280MG BASEEQ 70MG BASE/SMLlOMGIMLlOMG/ML10MGI'30ML10MG/30ML20MG/30Ml * 30MG/30Ml * 40MG/30Ml *SOHG/30Ml * 60MG/30Ml * 70MG/30Ml *80MG/30Ml * 90MG/30Ml * lOOMG/30Ml5HG * lONG40MGTABLET, EFFERVESCENT; ORALWESTADONEVITARINE/WEST CHEM 2.5MG * 5MG * lOMG * 40MGMETHAMPHETAMINE HYDROCHLORIDETABLET; ORALDESOXYHAA ABBOTT lABS 5MB2.5MGMETHAMPEXAA lEMMON PHARMACAL 10MBMETHAMPHETAMrHE HClAA REXAR PHARMACAL 5MB IE .!.9.M§TABLET, CONTROllED RELEASE; ORALDESOXYNABBOTT lABSMETHANTHELINE BROMIDEINJECTABLE; INJECTIONBANTHINESEARLETABLET; ORALBANTHINESEARLEMETHAQUALONETABLET; ORALQUAALUDEA8 LEMNON PHARMACALSOPORBP ARNAR-STONE lABSMETHAqUALONE HYDROCHLORIDECAPSULE; ORALPAREST-200PARKE-DAVIS/W-LPAREST-400PARKE-DAVIS/W-l5MG * lOMG * 15MGSOMGI'VIAL50MG150MB • 500MG150MG * 300HG75MGEQ 175MG BASEEQ 350MG BASE
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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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j./APPROVED PRESCRIPTION DRUG PRODU
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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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