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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST114PROPANTHELINE BROMIDETABLET; ORALPROPAHTHELrHE BROMrDEAA PHILIPS ROXANE LABS 7.5MG M 15MGAA PRIVATE FORMULATIONS 15MGAA RICHLYN LABS lSMGAA TABLICAPS 15MGTABLET, CONTROLLED RELEASE; ORALPRO-BANTHINESEARLE30MGPROPARACAINE HYDROCHLORIDESOLUTION/DROPS; OPHTHALMICALCAIHEAT ALCON LABS O.5?OFHTHArHEAT ER SQUIBB AND SONS O.5?OPHTHETrCAT ALLERGAN PHARMS O.5?PROPARACArHE HelAT BARNES-HIND PHARMS O.5?PROPIOLACTONESOLUTION; IRRIGATIONBETAPRONEOJF/CHROMALLOYPROPIOMAZINE HYDROCHLORIDEINJECTABLE; INJECTIONLARGONWYETH LABS/AtlHO99l20MG/MLPROPOXYCAINE HYDROCHLORIDE; *MULTIPLE*SEE LEVARTERENOL BITARTRATE; PROCAINE HYDROCHLORIDE;PROPOXYCAINE HYDROCHLORIDESEE LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINEHYDROCHLORIDEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAPROPOXYPHENE HYDROCHLORIDECAPSULE; ORALDARVOHELI LILLY!ZMG * 65MGDOlEHELEDERLE LABS/AM CYAN 6511GKESSO-GESrCMK LABS 65MGPROPOXYFHEHE HCLANABOLIC6511GBARR LABS6511GCHELSEA LABS6511GCORD LABS65MGDANBURY PHARMACAL 65MGFEDERAL PHARMACAL !211G M 65MGGENERIC PHARM/IVY 6511GICN PHARMS65MGMYLAN PHARMS !211GNATCON CHEMICAL 65MGPHILIPS ROXANE LABS !2MG * 65MGPREMO PHARM LABS 65MGPRIVATE FORMULATIONS !2MG M 65MGPUREPAC PHARM65MGRICHLYN LABS65MGTOWNE PAULSEN65MGWEST-\oI.tlRD65MGZENITH .LABS32MG M 6511GPROFOXYFHEHE HCL 65PARKE-DAVIS/W-L 65MGSK-65SKF LABS6511GTABLET; ORALUNIGESICUPJOHN65MGPROPOXYPHENE HYDROCHLORIDE; *MULTIPLE*SEE ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDESEE ASPIRIN; CAFFEINE; PHENACETIN; PROPOXYPHENE HYDROCHLORIDESEE ASPIRIN; PROPOXYPHENE HYDROCHLORIDEPROPOXYPHENE NAPSYLATESUSPENSION; ORALDARVON-NELI LILLY50MG/5ML'-'
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST115PROPOXYPHENE NAPSYLATETABLET; ORALDARVON-NEL:J: LILLYlOOMGPROPOXYPHENE NAPSYLATEi *MULTIPLE*SEE ACETAMINOPHEN; PROPOXYPHENE NAPSYLATESEE ASPIRIN; PROPOXYPHENE NAPSYLATEPROPRANOLOL HYDROCHLORIDEINJECTABLE; INJECTIONINDERALAYERST LABS/AMHOTABLET; ORALINDERALAYERST LABS/AMHOlMG/MLlOMG * 20MG * 40MG * 80MGPROPRANOLOL HYDROCHLORIDE; *MULTIPLE*SEE HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDEPROPYlIODONESUSPENSION; INTRATRACHEALDIONOSIl AQUEOUSPICKER 50/.DIONOSIL OILYPICKER 60/.PROPYlTHIOURACILTABLET; ORALPROPYlTHIOURACILBD ANABOLICBD BARR LABSBD BELL PHARMACALBD CHELSEA LABSBD DANBURY PHARMACALBD ELI LILLYSOMGSOMG50MG50MG50MGSOMGPROPYlTHIOURACILTABLET; ORALPROPYLTHIOURACILBD GENERIC PHARM/IVYBD HALSEY DRUGBD LANNETTBD LEDERLE LABS/AM CYANBD MYLAN PHARMSBD PARKE-DAVIS/W-LBD PUREPAC PHARMBD RICHLYN LABSBD TABLICAPSBD WEST-WARDBD ZENITH LABSPROTAMINE SULFATEINJECTABLE; INJECTIONPROTAMINE SULFATEELI LILLYUPJOHNPROTIRELININJECTABLE; INJECTIONRELEFACT TRHAP HOECHST-ROUSSELTHYPJ:HOHEAP ABBOTT LABSPROTOKYLOL HYDROCHLORIDETABLET; ORALVENTAIREMARION LABSPROTRIPTYLINE HYDROCHLORIDETABLET; ORALVIVACTIlMERCK SHARP & DOHMESOMGSOMGSOMG50MGSOMGSOMGSOMGSOMGSOMGSOMGSOMGlOMGIMLSOMG/VIAL500 UGH/HL500 UGH/i'lL2MGSMG * lOMG
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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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PRESCRIPTION DRUG PRODUCTS DEEMED A
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