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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST26CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATETABLET; ORALARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATEWINTHROP L/STERLING EQ 300MG BASE;EQ 45MG BASECHLOROTHIAZIDESUSPENSIOtH ORALDIURILMERCK SHARP & DOHME2S0MG/SMLTABLET; ORALCHLOROTHIAZIDEAB BOLAR PHARM ~AB CAMALL ~AS DANBURY PHARMACAL ~AS LEDERLE LABS/AM CYAN 2S0HGBDSOOMGAS MYLAN PHARMS 2S0HGBD500NGDIURILAS MERCK SHARP & DOHME 2S0HGBD500MGCHLOROTHI6.ZIDE SODIUMINJECTABLE; INJECTIONDIURILMERCK SHARP & DOHMECHLOROTHIAZIDE; METHYLDOPATABLET; ORALALDOCLOR-ISOMERCK SHARP & DOHMEALDOCLOR-250MERCK SHARP & DOHMECHLOROTHIAZIDE; RESERPINEEQ 500MG BASE/VIAL150MG;250MG250MG;250MGTABLET; ORALCHLOROTHIAZIDE W/ RESERPINEBP BOLAR PHARM 250MG;12S UGMCHLOROTHIAZIDE; RESERPINETABLET; ORALDIUPRES-250BP tlERCK SHARP & DOHME 2S0MG;12S UGMDIUPRES-500MERCK SHARP & DOHME SOOMG;12S UGMCHLOROTRIANISENECAPSULE; ORALCHLOROTRIAHISEHEAA BANNER GELATIN PRODS l2MGTACEAA MERRELL-NATIONAL ~25MG * 72MGCHLOROXINESHAMPOO; TOPICALCAPITROLWESTWOOD PHARMSCHLORPHENESIN CARBAMATETABLET; ORALMAO LATEUPJOHNCHLORPHENIRAMINE MALEATEINJECTABLE; INJECTIONCHLOR-TRIMETOH2X400MGAP SCHERING lOMG/ML * 100MG/MLCHLORPHEHIRAMIHE MALEATEAP BEL-MAR LABS lOMG/MLAP CARTER-GLOGAU LABS lOMG/ML * 100MG/MLAP D-M PHARMACEUTICALS 10MG/NLAP ELKINS-SINN/AHROBINS 10MG/NLAP VITARINE/WEST CHEM lOMG/NLPYRIDAMAL 100AP BEL-MAR LABS lOONG/ML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST27CHLORPHENIRAMINE MALEATESYRUP; ORALCHLOR-TR!:METOHAA SCHERING 2MG/SMLCHLOR!DAHIHEAA NATL PHARM MFG/BARRE 2MG/SMLCHLORPHENIRAMINE MALEATENATCON CHEMICAL 2.5MG/5MLH:rSTREYAA BOWMAN PHARMS 2MG/5MLTABLET; ORALAHTAGOHATEAA DOME LABS/MILES LABS 4MGCHLOR-TR:rMETOHAA SCHERING 4MGCHLORPHEH!RAM!:HE MALEATEAA ANABOLIC 4MGAA BARR LABS 4MGAA BELL PHARMACAL 4MGAA BOLAR PHARM 4MGAA CHELSEA LABS 4MGAA CORD LABS 4MGAA DANBURY PHARMACAL 4MGAA GENERIC PHARM/IVY 4MGAA HALSEY DRUG 4MGAA ICN PHARMS 4MGAA KETCHUM LABS 4MGAA LEDERLE LABS/AM CYAN 4MGAA LEMMON PHARMACAL 4MGAA MARSHALL PHARMACAL 4MGAA MYLAN PHARMS 4MGAA NEWTRON PHARMS 4MGAA PANRAY/ORMONT DRUG 4MGAA PHARMAVITE PHARMS 4MGAA PHILIPS ROXANE LABS 4HGAA PHOENIX LABS 4MGAA PRIVATE FORMULATIONS 4MGAA PUREPAC PHARM 4MGAA RICHLYN LABS ~AA TABLICAPS 4MGAA TOWNE PAULSEN 4MGAA WEST-W.A.RD 4MGAA ZENITH LABS 4MGPHEHETROHAA LANNETT 4MGCHLORPHENIRAMINE MALEATETABLET, CONTROLLED RELEASE; ORALCH LOR - TR IMETONSCHERING12MGCHLORPHENOXAMINE HYDROCHLORIDETABLET; ORALPHENOXENEDOW PHARMS50MGCHLORPHENTERMINE HYDROCHLORIDETABLET; ORALPRE-SATEPARKE-DAVIS/W-LCHLORPROMAZINE HYDROCHLORIDEEQ 65MG BASECAPSULE, CONTROLLED RELEASE; ORALTHORAZINESKF LABSCONCENTRATE; ORALCHLORPROMAZ!HE HCLAA LEDERLE LABS/AM CYAN lOOMG/MLSOHAZJ:HE30MG * 75MG * 150MG * 200MG * 300MGAA CORD LABS 30MG/ML * lOOMG/MLTHORAZIHEAA SKF LABS 30MG/ML * lOOMG/MLINJECTABLE; INJECTIONCHLORPROMAZIHE HCLAP BEECHAM LABS 25MG/MLAP D-M PHARMACEUTICALS 25MG/MLAP ELKINS-SINN/AHROBINS 25MG/MLAP LYPHO-MED 2SMG/MLAP WYETH LABS/AMHO 2SMG/MLKLDRAZIHEAP CARTER-GLOGAU LABS 25MG/MLTHORAZIHEAP SKF LABS 25MG/ML
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RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
Page 12 and 13: products that have been approved" i
Page 14 and 15: To assist the user in relating the
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Page 20 and 21: B - Drug products that FDA does not
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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first edition (1980) of the Orange Book - FDA Law Blog

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