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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST60GLUTETHIMIDEGONADOTROPIN, CHORIONICTABLET; ORALGLUT ETHJ:MrO EAA DANBURY PHARMACALAA LANNETTAA NO PHARNAA ZENITH LABS500MG250MG IE500MG500MG500MGINJECTABLE; INJECTIONPREGHYLAP ORGANON/AKZONA 10,000 UH:tTS/VJ:ALGRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATEAAAAAAAAGLYCOPYRROLATEINJECTABLE; INJECTIONROBINlJLAH ROBINSORALGlYCOPYRROlATEBOLAR PHARNCHELSEA LABSROBJ:HUlAH ROBINSROBJ:HUL FORTEAH ROBINSTA~LET;GONADOTROPIN, CHORIONICINJECTABLE; INJECTIONA.P.l.AI' AYERST LABS/AMHOAPAPAPAPAI'AI'APAPAI'AI'I'll'AHTU:ITRJ:H SPARKE-DAVIS/W-LCXORJ:OHJ:C GOHADOTROPJ:HBEL-MAR LABSCARTER-GLOGAU LABSLVPHO-MEDFOLLUTEniER SQUIBB AND SONS200 UGM/ML1MG IE 2MG2MGIMG2MG5,000 UHJ:TS/VJ:AL IE10,000 UHJ:TS/VJ:AL IE20,000 UNJ:TS/VJ:AL5,000 UNJ:TS/VJ:AL5,000 UHJ:TS/VJ:AL IE 10,000 UHJ:TS/V:tAL5,000 UHJ:TS/VJ:AL IE10,000 UHJ:TS/VJ:AL IE20,000 UHJ:TS/VJ:AL5,000 UHJ:TS/VJ:Al IE10,000 UHJ:TS/VJ:AL IE20,000 UHJ:TS/VJ:AL15,000 UNITS/VIAL10,000 UH:tTS/V:tALSOLUTION/DROPS; OPHTHALMICHEO-POLYCJ:HAT DOW PH ARMS 25 UGM/ML;EQ 1.75MG BASE/ML;AT5.000 UHJ:TS/MLHEOSPORJ:HAT BURROUGHS WELLCOME 25 UGM/ML;Eg 1.75MG BASE/Ml;AT5.000 UHJ:TS/MLGRISEOFULVIN, MICROCRYSTALLINECAPSULE; ORALGRJ:SACTJ:HA8 AYERST LABS/AI1HO 250MG12511GGRJ:SOWEHAS OWEN LABS/ALCON LABS 250MGSUSPENSION; ORALGRIFULVIN V.ORTHO PHARM125MG/5MLTABLET; ORALFULV:rCJ:H-U/FAS SCHERING 250MG IE 500MGGRJ:FULVIH VAS ORTHO PHARM 250MG IE 500MG125MGGRJ:SACTJ:HAD AYERST LABS/AMHO 500MGGRISEOFULVIN, ULTRAMICROCRYSTALlINETABLET; ORALFIJLV:tCZH-P/GAS SCHER!NG 125MG IE 250MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST"- ---~.,61GRISEOFULVIN, ULTRAMICROCRYSTALLINETABLET; ORALGR:rS-PEGAB DORSEY LABS/SANDOZGR:rSACTZH ULTRAlZSMGAB AYERST LABS/AMHO lZ5MG M Z50MGGUANETHIDINE MONOSULFATEj HYDROCHLOROTHIAZIDETABLET; ORALESIMILCIBA PHARMGUANETHIDINE SULFATETABLET; ORALISMELINCIBA PHARMGUANIDINE HYDROCHLORIDETABLET; ORALGUANIDINE HCLKEY PHARMSHALCINONIDECREAM; TOPICALHALC:rDERMAT ER SQUIBB AND SONSHALOSAT ER SQUIBB AND SONSHALOGER SQUIBB AND SONSOINTMENT; TOPICALHALOGER SQUIBB AND SONSSOLUTION; TOPICALHALOGER SQUIBB AND SONSIOMG;25MG10MG * 25MG125MGo.l?0.17-O.025XO.025XO.l?o .IXHALOPERIDOLCONCENTRATE; ORALHALDOLMCNEIL LABSINJECTABLE; INJECTIONHALDOLMCNEIL LABSTABLET; ORALHALDOLMCNEIL LABSHALOPROGINCREAM; TOPICALHALOTEXWESTWOOD PHARMSSOLUTION; TOPICALHALOTEXWESTWOOD PHARMSHALOTHANE2MG/ML5MG/MLLIQUID; INHALATIONFLUOTHAHEAH AYERST LABS/AMHO 99.997-HALOTHAHEAH ABBOTT LABS 1007-AH AMERICAN HOSP SUPPLY 99.99?AH HALOCARBON LABS ~HEPARIN SODIUM500 UGM * IMG * 2MG * 5MG * 10MGINJECTABLE; INJECTIONHEP-LOCKAP ELKINS-SINN/AHROBINS 10 UH:rTS/ML M 100 UH:rTS/MLHEPAR:rHAP LEDERLE LABS/AM CYAN 20,000 UH:rTS/MLHEPAR:rH LOCK FLUSHAP ABBOTT LABS 100 UH:rTS/MLlXIX
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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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