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

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APPROVED PRESCRIPrION DRUG PRODUCTSDRUG PRODUCT LIST14BACITRACIN ZINCPOWDER; FOR RX COMPOUNDINGZIBA-RXPHARMA-TEK500,000 UNITS/BOTBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT; OPHTHALMICBAC~TRAC~H-HEOMYC~H-POLYMYX~H BATATBYK-GULDEN 400 UH~TS/GM;EQ5,000 UH~TS/GM3.5MG BASE/GM;NEO-POLYCINDOW PHARMS500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMHEOSPOR~HAT BURROUGHS WELLCOME 400 UH~TS/GM;Eg 3.5MG BASE/GM;AT5,000 UH~TS/GMPOLYSPECTR~H S.O.P.AT ALLERGAN PH ARMS 400 UH~TS/GM;Eg 3.5MG BASE/GM;AT5,000 UH~TS/GMBACITRACIN ZINC; POLYMYXIN B SULFATEOINTMENT; OPHTHALMICPOLYSPORINBURROUGHS WELLCOME500 UNITS/GMilO,OOO UNITS/GMBACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT; OPHTHALMICMYCITRACINUPJOHN500 UNITS/GMiEQ 3.5MG BASE/GM;5,000 UNITS/GMBECLOMETHASONE DIPROPIONATEAEROSOL; INHALATIONBECLOVENTBN GLAXO INCVANCERILBN SCHERINGBENDROFLUMETHIAZIDETABLET; ORALNATURETIN-IOER SQUIBB AND SONSNATURETIN-2.5ER SQUIBB AND SONSNATURETIN-5ER SQUIBB AND SONSBENOXINATE HYDROCHLORIDE8.4MG/16.8GM8.4MG/16.8GM10MG2.5MG5MGSOLUTION/DROPS; OPHTHALMICBEHOX~HATE HCLAT BARNES-HIND PHARMS 0.4~DORSACA~HEAT DORSEY LABS/SANDOZ 0.4?BENTONITE; SULFURPOWDER; TOPICALBENSULFOIDWILLIAM P POYTHRESSBENZONA.TATE66.64Y.i33.32Y.BACLOFENTABLET; ORALLIORESALGEIGY PH ARMS10MGCAPSULEi ORALTESSA LONENDO LABS/DUPONTBENZPHETAMINE HYDROCHLORIDE100MGTABLET; ORALDIDREXUPJOHN25MG * SOMG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST152:QUINAMIDE HYDROCHLORIDEINJECTABLE; INJECTIONEMETE-CONROERIG/PFIZERSUPPOSITORY; RECTALEMETE-CONROERIG/PFIZERBENZTHIAZIDETABLET; ORALAQUATAGBP CORD LABSBPEQ 50MG BASE/VIALEQ 100MG BASE50MG25MGBENZTHIAZIDEPRIVATE FORMULATIONS 50MGEXNABP AH ROBINS 50MGFOVANEBP PFIZER LABS 50MGPROAQUABP REID-PROVIDENT LABS 50MGBENZTHIAZIDEj RESERPINETABLET; ORALEXNA-RAH ROBINSBENZTROPINE MESYLATEINJECTABLE; INJECTIONCOG ENTINMERCK SHARP & DOHMETABLET; ORALCOG ENTINMERCK SHARP & DOHME50MG;I25 UGMIMG/MLSOO UGM * IMG * 2MGBENZYL BENZOATEEMULSION; TOPICALBENZYL BENZOATELANNETT50XBENZYL PENICILLOYL-POLYLYSINEINJECTABLE; INJECTIONPRE-PENKREMERS-URBANBETAMETHASONECREAM; TOPICALCELESTONESCHERINGSYRUP; ORALCELESTONESCHERINGTABLET; ORALCELESTONESCHERING60 UMOLAR0.2?600 UGM/5ML600 UGMBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATEINJECTABLE; INJECTIONCELESTONE SOLUSPANSCHERINGBETAMETHASONE BENZOATECREAM; TOPICALBENISONEPARKE-DAVIS/W-LGEL; TOPICALBENISONEPARKE-DAVIS/W-LLOTION; TOPICALUTICORTPARKE-DAVIS/W-L3MG/ML;EQ 3MG BASE/ML0.02S?0.02S7o0.02S?
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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