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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST134TIMOLOL MALEATESOLUTION/DROPS; OPHTHALMICTIMOPTICMERCK SHARP & DOHME EQ 0.25% BASE * EQ 0.5% BASETOBRAMYCIN SULFATEINJECTABLE; INJECTIONNEBCINELI LILLYTOLAZAMIDETABLET; ORALTOLINASEUPJOHNTOLBUTAMIDETABLET; ORALORIHASEAS UPJOHNEQ 10MG BASE/ML * EQ 40MG BASE/ML *EQ 1.2GM BASE/VIAL100MG * 250MG * 500MGSOOMG250MGSK-TOLSUTAMIDEAS SKF LABS SOOHGTOLBUTAMIDEAB CHELSEA LABS SOOMGAB CORD LABS SOOMGABLEDERLE LABS/AM CYAN SOOMGTOLHETIN SODIUMCAPSULE; ORALTO LECTIN DSMCNEIL LABSTABLET; ORALTO LECTINMCNEIL LABSTRETINOINCREAM; TOPICALRETIN-AORTHO PHARMGEL; TOPICALRETIN-AOR THO PHARMLIQUID; TOPICALRETIN-AORTHO PHARMSWAB; TOPICALRETIN-AORTHO PHARMTRIAMCINOLONETABLET; ORALARISTOCORTEQ 400MG BAsEEQ 200MG BASE0.05% * 0.125%0.01% * 0.025% * 0.05%AB MYLAN PHARMS SOOMG BP LEDERLE LABS/AM CYAN IMG * 2MG * 4MG * 8MGAB PARKE-DAVIS/W-L SOOMGAB PREMO PHARM LABS SOOMGAB ZENITH LABS SOOMGTOLBUTAMIDE SODIUMINJECTABLE; INJECTIONORINASEUPJOHNEQ IGM BASE/VIALBPBPBPBPBPBPBPBPKENACORTER SQUIBB AND SONSTRIAMCINOLONEBARR LABSBOLAR PHARMCHELSEA LABSCORD LABSDANBURY PHARMACALFEDERAL PHARMACALMYLAN PHARMS0.05%0.05%16MGIMG * 2MG * 4MG * 8MG2MG * 4MG * 8MG4MG4MG4MG4MG4MG2MG * 4MG * 8MG,
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST135TRIAMCINOLONETABLET; ORALTRIAMCINOLONEBP PHILIPS ROXANE LABSBP PUREPAC PHARMBP RICHLYN LABSBP ZENITH LABSTRIAMCINOLONE ACETONIDEAEROSOL; TOPICALKENALOGER SQUIBB AND SONS2MG * 4MG * 8MG2MG * 4MG4MG4MG147 UGM/GMCREAM; TOPICALARrSTOCORTAT LEDERLE LABS/AM CYAN 0.0257. * 0.17. * 0.57.ARrSTOCORT AAT LEDERLE LABS/AM CYAN ~ * 0.17. * 0.57.FLUTEXAT SYOSSET LABS 0.0257. * 0.17.* 0.57.KEHAlOGAT ER SQUIBB AND SONS 0.0257. * 0.17. * 0.57.KEHALOG-HAT ER SQUIBB AND SONS 0.17.TRrACETAT PREMO PHARM LABS 0.0257. * O.lX * 0.57.TRrAMCrHOlOHE ACETOHrOEAT BYK-GUlDEN 0.0257. * 0.17. * 0.57.AT SHAFFER-DAVIS LABS ~ * 0.17. * 0.57.GEL; TOPICALARISTOGELLEDERLE LABS/AM CYAN O.lXINJECTABLE; INJECTIONKENALOG-IOER SQUIBB AND SONSKENALOG-40ER SQUIBB AND SONSLOTION; TOPICALKENALOGER SQUIBB AND SONS10MG/ML40MG/ML0.0257. * O.lXTRIAMCINOLONE ACETONIDEOINTMENT; TOPICALARrSTOCORTAT LEDERLE LABS/AM CYAN 0.17. * 0.57.ARrSTOCORT AAT LEDERLE LABS/AM CYAN 0.17. * 0.57.KEHALOGAT ER SQUIBB AND SONS 0.0257. * 0.17. * 0.57.TRrAMCrHOLOHE ACETOHrOEAT BYK-GULDEN 0.0257. * 0.17. * 0.57.PASTE; DENTALKENALOG IN ORABASEER SQUIBB AND SONSTRIAMCINOLONE DIACETATEO.lXINJECTABLE; INJECTIONARISTOCORTBP LEDERLE LABS/AM CYAN 25MG/ML * 40MG/MLTRIAMCINOLONE DIACETATEBP CARTER-GLOGAU LABS 40MG/MLBP D-M PHARMACEUTICALS 40MG/MLBP MAURRY BIOLOGICAL 25MG/MLSYRUP; ORALARISTOCORTLEDERLE LABS/AM CYAN 2MG/5MLKENACORTER SQUIBB AND SONS EQ 4MG BASE/5MLTRIAMCINOLONE HEXACETONIDEINJECTABLE; INJECTIONARISTOSPANLEDERLE LABS/AM CYAN 5MG/ML * 20MG/MLTRIAMTERENECAPSULE; ORALDYRENIUMSK&F50MG * lOOMG
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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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-,----APPROVED PRESCRIPTION DRUG PR
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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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