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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST82MENADIONETABLET; ORALMENADIONEELI LILLYSMGMEPERIDINE HYDROCHLORIDE; *MULTIPLE*SEE ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDEMEPEt~ZOLATEBROMIDELIQUID; ORALCANTILMERRELL-NATIONAL2SMG/SMLINJECTABLE; INJECTIONHEPERGANWYETH LABS/AMHOMEPHENTERMINE SULFATE25MG/ML;25MG/MLTABU:.T; ORALCANTILMERRELL-NATIONAL2SMGINJECTABLE; INJECTIONWYAMINE SULFATEWYETH LABS/AMHOI5MG/ML * 30MG/MLMEPERIDINE HYDROCHLORIDEINJECTABLE; INJECTIONDEHEROLAP WINTHROP LISTER LING ZSHG/HL M SOMG/ML M 7SMG/ML MAPlOOMG/HlMEPERIDIHE HClAP ELKINS-SINN/AHROBINS ZSMG/ML M 50MG/Ml M 7SMG/HL MAPlOOMG/MLINT'L MEDICATION SYS IOMG/MLAP KNOLL PHARM ZSMG/ML M SOMG/ML M 7SMG/HL MAPlOOMG/HlAP PARKE-DAVIS/W-L SOMG/ML M 7SMG/ML M lOOMG/MLAP VITARINE/WEST CHEM SOMG/ML M lOOMG/MLAP WYETH LABS/AMHO ZSMG/HL M SOMG/HL M 7SMG/ML MAPlOOHG/MLSYRUP; ORALDEHEROLWINTHROP LISTER LINGSOMG/SMLTABLET; ORALDEHEROLAA WINTHROP LISTER LING SOMG M lOOMGMEPERIOINE HCLAA HALSEY DRUG SOHG M lOOMGAA WYETH LABS/AMHO SONGMEPHENYTOINTABLET; ORALMESANTOINSANDOZ PHARMSMEPIVACAINE HYDROCHLORIDEINJECTABLE; INJECTIONARF.STOCAIHE HCLAP CARLISLE LABSCARBOCAIHE HCLBREON LABS/STERLINGAP COOK-WAITE/STERLINGISOCAIHE HClAP NOVOCOL CHEM MFGMEPIVACAIHE HCLAP GRAHAM CHEMICALIOOMG3?IX * 1. 5X * 2X3?MEPIVACAINE HYDROCHLORIDE; *MULTIPLE*SEE LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDEME PREDNISONETABLET; ORALBETAPARSCHERING3?3?4MG... --~"
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST83AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAMEPROBAMATECAPSULE; ORALEQUANILWYETH LABS/AMHO400MGCAPSULE, CONTROLLED RELEASE; ORALMEPROSPANWALLACE PHARMS/C-W 200MG * 400MGTABLET; ORALAMOSEHEFERNDALE LABS 400MGEQUAHILWYETH LABS/ANHO ZOOMG " 400MGMEPR:tAMLEMMON PHARMACAL 400MGMEPROBAMATEANABOLICZOOMG " 400MGBARR LABSZOOMG " 400MG " 600MGBELL PHARMACALZOOMG " 400MGBOLAR PHARM ZOOMG " ~CHELSEA LABSZOOMG " 400HG w 600MGCORD LABS400MGDANBURY PHARMACAL ZOOMG W 400MG W 600MGFIRST TEXAS PH ARMS 400MGGENERIC PHARtVIVY 400MGHEATHER DRUG400MG " 600MGICN PH ARMSZOOMG W 400MGKETCHUM LABSZOOMG W 400HGLANNETTZOOMG W 400MGLEDERLE LABS/AM CYAN ZOOMG W 400MGMALLARD400MGMK LABS ZOOMG W 400MGMM MAST ZOOMG W 400MGMYLAN PHARMSZOOMG'" 400MG W 600MGPARKE-DAVIS/W-L ZOOMG W 400MGPHARNAVITE PHARMS 400MGPHILIPS ROXANE LABS ZOOMG" 400MG " 600MGPREMO PHARM LABS ZOOMG W 400MGPRIVATE FORMULATIONS 400HGPUREPAC PHARMZOOMG " 400MGREID-PROVIDENT LABS ZOOMG W 400MGREXALL DRUG400MGRICHLYN LABSZOOMG W 400MGSTAN LABS PHARMZOOMG * 400MGMEPROBAMATETABLET; ORALMEPROBAMATEAA TABLICAPS 400MGAA TOWNE PAULSEN ZOOMG * 400MGAA WEST-WARD ZOOMG * 400MGAA ZENITH LABS ZOOMG * 400MG * 600MGM:rLTOWHAA WALLACE PHARMS/C-W ZOOMG * ~ * 600MGHEURAMATEAA HALSEY DRUG ZOOMG * 400MGSK-BAMATEAA SKF LABS ZOOMG W 400MGTRAHMEPAA REID-PROVIDENT LABS 400MGMEPROBAMATE; *MULTIPLE*SEE ASPIRIN; MEPROBAMATESEE ESTROGENS, CONJUGATED; MEPROBAMATEMERCAPTOMERIN SODIUMINJECTABLE; INJECTIONTHIOMERIN SODIUMWYETH LABS/AMHOMERCAPTOPURINETABLET; ORALPURINETHOLBURROUGHS WELLCOMEMERSALYL SODIUM; THEOPHYLLINEINJECTABLE; INJECTIONMERSALYL-THEOPHYLLINECARTER-GLOGAU LABSMESORIDAZINE BESYLATECONCENTRATE; ORALSERENTILSANDOZ PHARMS125MG/ML50MG100MG/ML;50MG/MLEQ 2SMG BASE/ML
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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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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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