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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST64HOMATROPINE METHYLBROMIDETABLET; ORALHOMAPIN-SMISSION PHARMACALSEDS-TEHS SEAA LEMMON PHARMACALTABLET, CHEWABLE; ORALEQUIPINMISSION PHARMACALHYALURONIDASESMGlOMS3MGINJECTABLE; INJECTIONAlXDASEAP SEARLE PHARMS 150 UHXTS/VXAl~AP WYETH LABS/AMMO 150 UHXTS/VXAl150 UNITS/ML * 1,SOO UNITS/VIALAAAAAAAAAAAAAAAAAAAAAAAAAAHYDRALAZINE HYDROCHLORIDEINJECTABLE; INJECTIONAPRESOllNECIBA PHARM20MG/MLTABLET; ORALAPRESOlXHECIBA PHARM lOM~ w 2SMGDRAlZXHELEMMON PHARMACAL 2SMGHYDRAlAUHE HelBARR LABS 2SM~ w SOMGBOLAR PHARM2SMG w SOMGCHELSEA LABSZSMG W SOMGCORD LABSlOMG W 2SMGDANBURY PHARMACAL ZSMG W SOMGLEDERLE LABS/AM CYAN 2SM~ IE SOM~LEMMON PHARMACALZSM~PAR PHARM2SMG W SOM~PREMO PHARM LABS ~ IE SOM~RICHLYN LABSZSMG W SOMGZENITH LABSlOMG W 2SM~IE SOM~IESOMGW ill!1!lIE SOMG IE lOOMGHYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDECAPSULE; ORALAPRESAZIDECIBA PHARMTABLET; ORALAPRESOlXHE-ESXDRIXAB CIBA PHARM25H~;15H~HYDRALAZINE AND HYDROCHLORTHIAZIDEBP CHELSEA LABS25MG;15MGHYDROCHLOROTHIAZIDE W/ HYDRALAZINEBP BOLAR PHARM25MG;15MG2SMG;2SMG * 50MG;SOMG * 100NG;SOMGHYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINETABLET; ORALCAM-AP-ESBP CAMALL 2SMG;lSMG;lOO UGMHYDRALAZINE HCL, HYDROCHLOROTHIAZIDE AND RESERPINEBP ZENITH LABS 25MG;15MG;100 UGMHYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINEBP CHELSEA LABS 25MG;15MG;100 UGMHYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINEBP BOLAR PHARM 2SMG;15MG;100 UGM'HYDROCHLOROTHIAZIDE, HYDRALAZINE HCL AND RESERPINEBP DANBURY PHARMACAL 25MG;lSMG;100 UGMSER-A-GENBP REID-PROVIDENT LABS 2SMG;15MG;100 UGMSER-AP-ESBP CIBA PHARM 25MG;15MG;100 UGMUNIPRESBP REID-PROVIDENT LABS 25MG;lSMG;lOO UGMHYDRALAZINE HYDROCHLORIDE; RESERPINETABLET; ORALDRALSERPBP LEMMON PHARMACAL 2SMG;l00 UGMSERPASIL-APRESOLINEBP CIBA PHARM 2SMG;100 UGMSOMG;200 UGM"',--,."',-,.,...'"
----..//APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST65HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; METHYLDOPAT.6iBLET; ORALTABLET; ORALIESZDRZXALDORIl D30AB I CIBA PHARM2SMG * SONG * 100MGMERCK SHARP & DOHME 30MGi500MG;HYDRO-DALDORIL D50AB HALSEY DRUG2SMG * SOMGMERCK SHARP & DOHME 50MGi500MGHYDROCHLOROTHZAZIDEALDORIl 15AB BARR LABS2SMG SOMG 100MGMERCK SHARP & DOHME 15MG;250MGAB BOLAR PHARM2SMG SOMG * 100MGALDORIL 25AB CAMALL2SMG SOMGHERCK SHARP & DOHME 25MG;250MGAB CHELSEA LABS2SNG * SOMGAB CORD LABSSOMGAB DANBURY PHARMACAL SOMGHYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDEAB GENERIC PHARM/IVY 2SMG * SOMGAB HEATHER DRUGSONGTABLET; ORALAB INWOOD LABS/FOREST 2SMG * SOMGINDERIDEAB KETCHUM LABSSOMGAYERST LABS/AMHO 25MG;40MG * 25MG;80MGAB LEDERLE LABS/AM CYAN 2SMG SOMGAB HM MAST 2SMG ~AB MYLAN PHARMS2SMG SOMGHYDROCHLOROTHIAZIDE; RESERPINEAB PHILIPS ROXANE LABS2SMG * SOMGAB PREMO PHARM LABS SOHGTABLETi ORALAB PRIVATE FORMULATIONS 2SMG SOMGH.R.-50AB REID-PROVIDENT LABS 2SMG SOMG 'IBP TOWNE PAULSEN 50MG ;125 UGMAB RICHL YN LABS2SMG SOMG 'lOOMGHYDRO-RESERPAB TOWNE PAULSEN2SMG SOMG * ilOOMGBP CAMALL 50MG;125 UGMAB WEST -WARD 2SMG SOMG IHYDROCHLOROTHIAZIDE 101/ RESERPINEAB ZENITH LABS2SMG * SONG * 100MGBP BARR LABS 25MGi125 UGM * 50MG;125 UGMHYDROOZUR:tLBP BOLAR PHARM 25HG;125 UGM 50MG;125 UGMAB MERCK SHARP & DOHME 2SNG * SOMG * ~OOMGBP CHELSEA LABS 25MG;125 UGM 50MG;125 UGHORETrC -- -- -I--BP DANBURY PHARHACAL 25HGi125 UGH * 50MGi125 UGMAB ABBOTT LABS 2SNG * SOMG IBP GENERIC PHARM/IVY 25HG;125 UGM 50HG;125 UGHSK-HYDROCHLOROTHZAZZDEBP PHILIPS ROXANE LABS 25HG;125 UGH * 50NGi125 UGHAB SKF LABS 2SNG * SONG BP ZENITH LABS 25HG;100 UGM * 25NGi125 UGH * 50NGiBP100 UGM * 50HG;125 UGMHYDROPRES-25MYDROCHLOROTHIAZIDE; *MULTIPLE*BP MERCK SHARP & DOHME 25MG;125 UGMSEE OESERPIDINEi HYDROCHLOROTHIAZIDEHYDRO PRES-50SEE GUANETHIDINE MONOSULFATEi HYDROCHLOROTHIAZIDEBP HERCK SHARP & DOHME 50MG;l25 UGHSEE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDESERPASIL-ESIDRIX #1SEE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDEi RESERPINE BP CIBA PHARM25HG;100 UGMSEE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDESERPASIL-ESIDRIX #2BP CIBA PHARM50MGi100 UGM
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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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