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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST136TRIAMTERENE; *MULTIPLE*SEE HYDROCHLOROTHIAZIDE; TRIAMTERENETRICHLORHETHIAZIDETABLET; ORALAQUEXBP LANNETT 4HGMETAHYDRINBP MERRELL!..NATIONAL 2MG * 4MGNAQUABP SCHERING 2MG * 4MGTRICHLORMASBP HH MAST 4MGTRICHLORHETHIAZIDEBP BOLAR PHARH 4MGBP CAMALL 4MGBP CHELSEA LABS 2MG * 4MGBP DANBURY PHARMACAL 2MG * 4MGBP RJ;CHLYN LABS 4HGTRICHLORMETHIAZIDE; *MULTIPLE*SEE RESERPINE; TRICHLORHETHIAZIDETRICLOFOSLIQUID; ORALTRICLOSHERRELL-NATIONALTABLET; ORALTRICLOSMERRELL-NATIONALTRIDIHEXETHYL CHLORIDE1.5GH/l5ML750MGINJECTABLE; INJECTIONPATHILONLEDERLE LABS/AM CYAN lOMG/MLT1.BLET; ORALPATHILONLEDERLE LABS/AM CYAN 25MGTRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATEDROPS; OTICCERUMENEXPURDUE FREDERICKlOXTRIFLUOPERAZINE HYDROCHLORIDECONCENTRATE; ORALSTELAZINESK&FINJECTABLE; INJECTIONSTELAZINESK&FEQ IOMG BASE/MLEQ 2MG BASE/MLTABLET; ORALSTELAZINESK&F EQ lMG BASE * EQ 2MG BASE *EQ 5MG BASE * EQ lOMG BASETRIFLUPROMAZINESUSPENSION; ORALVESPRIN HIGH POTENCYER SQUIBB AND SONSTRIFLUPROMAZINE HYDROCHLORIDEINJECTABLE; INJECTIONVESPRINER SQUIBB AND SONSTABLET; ORALVESPRINER SQUIBB AND SONSTRIFLURIDINESOLUTION/DROPS; OPHTHALMICVIR OPTICBURROUGHS WELLCOME lXEQ 50HG HCL/5MLlOHG/HL * 20HG/HLlOMG * 25MG * 50MG------.'''.,',
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST~--_/-137TRIHEXYPHENIDYL HYDROCHLORIDECAPSULE, CONTROLLED RELEASE; ORALARTANELEDERLE LABS/AM CYAN 5MGTRIMETHAPHAN CAMSYLATEINJECTABLE; INJECTIONARFONADHOFFMANN-LA ROCHE500MG/I01'flAAAAAAAAAAElIXIR; ORALARTANELEDERLE LABS/AM CYAN 2MG/SMLTABLET; ORALARTAHELEDERLE LABS/AM CYAN 2MG * 5MGTREM:tHSCHERING2MG * 5MGTR:tHEXYPHEH:tDYl HelBOLAR PHARM2MG 5MGDANBURY PHARMACAL 2MG * 5MGTABLICAPS5MGTRIMEPRAZINE TARTRATECAPSULE, CONTROLLED RELEASE; ORALTEMARILSKF LABSEQ SMG BASETRIMETHOBENZAMIDE HYDROCHLORIDEINJECTABLE; INJECTIONTIGANBEECHAM LABSTRIMETHOPRIM100MG/MLTABLET; ORALPROlOPR:tMAB BURROUGHS WELLCOME lOOMGTR:rHPEXAB HOFFMANN-LA ROCHE lOOHGTRIMETHOPRIM;SEE SULFA~'ETHOXAZOLE;*MULTIPLE*TRIMETHOPRIMSYRUP; ORALTRIMIPRAMINE MALEATETEMARILSKF LABS EQ 2.5MG BASE/5ML CAPSULE; ORALSURMONTILTABLET; ORALTEMARILSKF LABSEQ 2.5MG BASEIVES LABS/AMHOTRIOLEIN, 1-131EQ 2SMG BASE * EQ 50MG BASETRIMETHADIONECAPSULE; ORALTRIDIONEABBOTT LABSSOLUTION; ORALTR ID !ONEABBOTT LABSTABLET; ORALTRIDIONEABBOTT LABS300MG200MG/SML150MGCAPSULE; ORALTRIOLEIN I 131MALLINCKRODTTRIOXSALENTABLET; ORALTRISORALENPAUL B ElDER100 UCI5MG
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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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-,----APPROVED PRESCRIPTION DRUG PR
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APPROVED PRESCRI~TIOHDRUG PRODUCTSD
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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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APPROVED ¥RESCRIPTION DRUG PRODUCT
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'''"APPROVED PRESCRIPTION DRUG PROD
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----..//APPROVED PRESCRIPTION DRUG
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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