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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST118RAUWOLFIA SERPENTINATABLET; ORALBPHIWOLFIABOWHAN PHARHS SOHG * 100HGBPHYSERPHOORE KIRK LABS SOMG * 100MGBPHYSER PINPHYSICIANS PRODS/ILC SOHGKOGLUCOIDBP PANRAY/ORMONT DRUG SOHG * 100MGBPRAUDIXINER SQUIBB AND SONS SOHG * 100HGBPRAUSER PINFERNDALE LABS SOHG * 100MGRAUTOTALBP PHILIPS ROXANE LABS SOHGRAUVALBP VALE CHEMICAL SOMG * 100MGRAUWOLFIA SERPENTINABP CH BUNDY SOHG 100HGBP CORD LABS SOHG 100HGBP DANBURY PHARHACAL SOHG 100MGBP HALSEY DRUG SOHG 100HGBP leN PHARMS SOMG 100MGBP KIRKMAN LABS SOHG * 100MGBP PHILIPS ROXANE LABS 100MGBP PRIVATE FORMULATIONS SOMG * 100HGBP PUREPAC PHARM SOMG * 100MGBP REID-PROVIDENT LABS SOMG * 100MGBP RICHLYN LABS SOMG * 100MGBP TABLICAPS SOMG * 100MGBP ZENITH LABS SOMG * 100HGRU-HY-TBP BOOTS PHARMS 100MGBPWOLFINAOJF/CHROMALLOYRESCINNAMINECAPSULE; ORALCINNASILPANRAY/ORMONT DRUGTABLET; ORALMODERILPFIZER LABSSOHG * 100MG500 UGM250 UGM * 500 UGHRESERPINEELIXIR; ORALSERP~SILCI~APHARMINJECTABLE; INJECTIONSAHDRJ:LAP ELI LILLYSERPASILAP CIBA PHARMSERPIVITEAP VITARINE/WEST CHEM200 UGM/4ML2.5MG/ML2.5MG/ML2.5MG/MLTABLET; ORALALKARAUBP FERNDALE LABS 250 UGMBPHISERPIABOWMAN PHARMS 100 UGM * 250 UGMBPLEMISERPLEMMON PHARHACAL 100 UGM * 250 UGMRAU-SEDBP ER SQUIBB AND SONSRAURINEBP OJF/CHROMALLOYRESERPINE250 UGNBP ANABOLICBP BARR LABSBP BELL PHARMACALBP BOLAR PHARMBP CHELSEA LABSBP CM BUNDYBP CORD LABSBP DANBURY PHARMACALBP GENERIC PHARM/IVYBP HALSEY DRUGBP ICN PHARHSBP KETCHUM LABSBP LEDERLE LABS/AM CYANBPBPMALLARDMARSHALL PHARMACALSP MK LABSBP MYLAN PHARMSSP PHARHAVITE PHARMSSF PHILIPS ROXANE LABSBP PRIVATE FORMULATIONS100 UGM * 250 UGM * 500 UGM * IHG250 UGM250 UGM100 UGM * 250 UGM250 UGH250 UGH100 UGH * 250 UGH100 UGH * 250 UGM100 UGH * 250 UGH * IMG250 UGM100 UGH * 250 UGN * ING100 UGN * 250 UGH100 UGN * 250 UGH250 UGN250 UGH100 UGH * 250 UGM100 UGM * 250 UGM100 UGM * 250 UGM * IMG250 UGH100 UGH * 250 UGM100 UGM * 250 UGM * IMS
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT lIST119RESERPINETABLET; ORALRESERPINEBP PUREPAC PHARH 100 UGH * 250 UGHBP REID-PROVIDENT LABS 250 UGHBP REXALL DRUG 100 UGH * 250 UGHBP RICHLYN LABS 100 UGH * 250 UGHBP STAN LABS PHARH 100 UGH * 250 UGH * 500 UGH * IHGBP TABLICAPS 100 UGH * 250 UGHBP TOWNE PAULSEN 100 UGH * 250 UGH * IHGBP WEST-WARD 100 UGH * 250 UGH * IHGBP ZENITH LABS 100 UGH * 250 UGHRESERPOID .BP UPJOHN 250 UGHBPRESINEKIRKMAN LABSSANDRIL100 UGM * 250 UGH * 500 UGH * IHGBP ELI LILLY 100 UGH * 250 UGHSERPALANBP LANNETT 100 UGH * 250 UGHSERPANRAYBP PANRAY/ORHONT DRUG 100 UGH * 250 UGH * IHGSERPASILBP CIBA PHARH 100 UGH * 250 UGH * IHGSERPATEBP VALE CHEHICALSERPIVITE100 UGH * 250 UGNBP VITARINE/WEST CHEH 250 UGHVIO-SERPHIEBP ROWELL LABS 100 UGH * 250 UGHRESERPINE; *HULTIPLE*SEE BENZTHIAZIDE; RESERPINESEE CHLOROTHIAZIDE; RESERPINE'SEE CHLORTHALIDONE; RESERPINESEE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINESEE HYDRALAZINE HYDROCHLORIDE; RESERPINESEE HYDROCHLOROTHIAZIDE; RESERPINESEE HYDROFLUMETHIAZIDE; RESERPINESEE HETHYCLOTHIAZIDEi RESERPINESEE POLYTHIAZIDEi RESERPINESEE gUINETHAZONE; RESERPINERESERPINE; TRICHLORHETHIAZIDETABLET; ORALHETATENSIN 2HERRELL-NATIONAL 100 UGH;2HGHETATH1SIN 4BP HERRELL-NATIONALNAQUIVAL100 UGH;4HGBP SCHERING100 UGH;4MGTRICHLORHETHIAZIDE WI RESERPINEBP BOLAR PHARH100 UGMi4MGRIFAHPINCAPSULE; ORALR:tFAD::tl!AS DOW PHARNSR:tMACTANEAB CIBA PHARHRIFANPIN; *NULTIPLE*SEE ISONIAZID; RIFAMPINSAFFLOWER OILINJECTABLE; INJECTIONLIPOSYN lOXABBOTT LABSSCOPOLAHINE HYDROBROMID£300MG300MGlOXFILM, CONTROLLED RELEASE; PERCUTANEOUSTRANSDERH-VALZA1.5HGSECOBARBITAL SODIUNCAPSULE; ORALSECOBARB:tTAL SOD:tUMAA lANNETT lOOMGSONG
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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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j./APPROVED PRESCRIPTION DRUG PRODU
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-,----APPROVED PRESCRIPTION DRUG PR
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APPROVED PRESCRI~TIOHDRUG PRODUCTSD
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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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