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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST110PREDNISONETABLET; ORALDELTA-DOHEBXDOHE LABS/HILES LABS 5HGDELTASONEBX UPJOHN 2.5HG * 5MG * 10HG * 20HG * 50HGFERNISONEBX FERNDALE LABS 5HGHETICORTENBX SCHERING IHG * 5HGBXORASONEROWELL LABS IHG * 5MG * 10HG * 20HG * 50HGPAt~-TRACEBX CORD LABS 5MGPARACORTBX PARKE-DAVIS/W-L 5MGPREDNICEN-MBX CENTRAL PHARMACAL 5MGPREDNISONEBX BARR LABS 5MG * 10MG * 20MG * 50HGBX BELL PHARMACAL 5MGBX CHELSEA LABS 5MG * 20MGBX CM BUNDY 5HGBX CORD LABS 5MG * 20MGBX DANBURY PHARMACAL 5MG * 10MG * 20MGBX FEDERAL PHARMACAL 5MGBX FIRST TEXAS PHARMS 5MGBX GENERIC PHARM/IVY 5MGBX HALSEY DRUG 5MGBX HEATHER DRUG 5MG * 10MG * 20MGBX HEUN-NORWOOD LABS 5MGBX ICN PHARMS 5MGBX INWOOD LABS/FOREST IMG * 2.5MG * 5MGBX KETCHUM LABS 5MGBX LANNETT 5MG * 20MGBX LEDERLE LABS/AM CYAN 5MGBX LEMHON PHARHACAL 5HGBX HK LABS 2.5MG * 5MGBX HYLAN PHARMS 5HGBX PANRAY/ORHONT DRUG IHG * 2.5MG * 5HGBX PHARHAVITE PHARMS 5HGBX PHILIPS ROXANE LABS 5HG * 10MG * 20MG * 50HGBX PHOENIX LABS 5HG * 20MGBX PREMO PHARH LABS 5MGBX PRIVATE FORMULATIONS 5HG * 20HGPREDNISONETABLET; ORALPREDNISONEBX PUREPAC PHARM 5MG * 10MG * 20HGBX REXALL DRUG 5MGBX RICHLYN LABS 5MGBX SPERTI DRUG PRODS IHG * 2.5MG * 5MGBX STAN LABS PHARM IMG * 2.5MG * 5MGBX STERI-HED/KETCHUM 20MGBX TABLICAPS 5HGBX TOWNE PAULSEN 2.5MG * 5MG * 20HGBX VITARINE/WEST CHEM 5MGBX WEST-WARD 5MG * 20HGBX ZENITH LABS 5MG * 10MG * 20MGBXSERVISONELEDERLE LABS/AM CYAN 5MGPRILOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONCITANESTASTRA PHARM PRODS l~ * 2X * 3X * 4XPRILOCAINE HYDROCHLORIDE; *MULTIPLE*SEE EPINEPHRINE; PRILOCAINE HYDROCHLORIDEPRIMAQUINE PHOSPHATETABLET; ORALPRIMAQUINEWINTHROP L/STERLINGEQ 15MG BASEPRIMAQUINE PHOSPHATE; *MULTIPLE*SEE CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATEPRIMIDONESUSPENSION; ORALMYSOLINEAYERST LABS/AMHO250MG/5ML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST111IPRIMIDONETABLET; ORALMYSOL:IHEAD AYERST LABS/AMHOABABADPR:IM:IDOHEBOLAR PHARMDANBURY PHARMACALLANNETTPROBENECID2S0MGSONG2S0MG2S0MG2S0MGTABLET; ORALBEHEM:IDAD NERCK SHARP & DOHME SOOMGPROBAlAHAB LANNETT SOOMGPROBEHECJ:DAB BEECHAM LABS SOOMGAB CHELSEA LABS SOOMGAB DANBURY PHARMACAL SOOMGAB LEDERLE LABS/AM CYAN SOOMGAB NYLAN PHARMS SOOHGPROBENECID; *MULTIPLE*SEE AMPICILLIN TRIHYDRATE; PROBENECIDSEE COLCHICINE; PROBENECIDPROBUCOLTABLET; ORALLORELCODOW PHARMSPROCAINAMIDE HYDROCHLORIDECAPSULE; ORALPROCAJ:HAMJ:DE HClAB BOLAR PHARMAB CHELSEA LABSAB DANBURY PHARMACAL250MG2S0MG lIf SOOMG2S0MG !II 37SMG • SOOMG2S0MG lIf 37SMG * SOOMGPROCAINAMIDE HYDROCHLORIDECAPSULE; ORALPROCA:IHAM:IDE HClAB LANNETT 2S0MG • SOOMGAB LEDERLE LABS/AN CYAN 2S0MG • 37SMG • SOOMGAB PARKE-DAVIS/W-L 2S0MG • SOOMGAB ZENITH LABS 2S0MG • 37SHG • SOOMGPROCAPAHAB PANRAY/ORMONT DRUG 2S0MGPROHESTYlAB ER SQUIBB AND SONS 2S0MG. 37SMG • SOOMGINJECTABLE; INJECTIONPRONESTYLER SQUIBB AND SONSTABLET; ORALPRONESTYLER SQUIBB AND SONSlOOMG/ML * 500MGIML2S0NG * 37SMG * SOOMGTABLET, CONTROLLED RELEASE; ORALPROCANPARKE-DAVIS/W-L 2S0MG * SOONGPROCAINE HYDROCHLORIDEINJECTABLE; INJECTIONHOVOCAJ:HAP BREON LABS/STERLING 11- * 21-lO/.PROCA:IHE HClAP ABBOTT LABS 1Z * 2?AP AM MCGAW/AM HOSP 11- * 2?AP BEL-MAR LABS 1? * 2?AP CARTER-GLOGAU 1? * 2?AP CUTTER LABS 1? • 2?AP D-M PHARMACEUTICALS 1? * 2?AP ELKINS-SINN/AHROBINS 1? • 2?AP INVENEX PHARMS/MOGUL 1? • 2?AP VITARINE/WEST CHEM 1?. 2?PROCAINE HYDROCHLORIDE; *HULTIPLE*SEE EPINEPHRINE; PROCAINE HYDROCHLORIDE
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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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oAPPROVED PRESCRIPTION DRUG PRODUCT
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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