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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATIOH HOLDER INDEX18IHGlUI!1 PtfARMDRICORT, HYDROCORTISONE ACETATEHYDROCORTISONE, HYDROCORTISONE:mOLEX CORPHEPARIN SODIUM, HEPARIN SODIUMIt/T'L MEOl:CATIOH SYSDIMENHYDRINATE, DIMENHYDRINATEDIPHENHYDRAMWE HCL, DIPHEt.'HYDRAMINE HYDROCHLORIDEFUROSEMIDE, FUROSEMIDEHEPARIN LOCK FLUSH, HEPARIN SODIUMISOETHARINE HCL, ISOETHARINE HYDROCHLORIDEISOPROTERENOL HCL, ISOPROTERENOL HYDROCHLORIDELARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDELIDOCAINE HCL W/ EPINEPHRINE, EPINEPHRINEMANNITOL, MANNITOLMEPERIDINE HCL, MEPERIDINE HYDROCHLORIDEMETARAMINOL BITARTRATE, METARAMINOL BITARTRATEPHYTONADIONE, PHYTONADID:IEPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEIHVENEX LABSIPRENOL, ISOPROTERENOL HYDROCHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDEOXYTOCIN, OXYTOCINPOTASSIUM CHLORIDE, POTASSIUM CHLORIDESODIUM HEPARIN, HEPARIN SODIUMIt/VEl/EX PtfM!!1S/tlOGULHEPARIN SODIUM, HEPARIN SODIUMMANNITOL, Nt.NNITOLMETARAMINOL BITARTRATE, METARAMINOL BITARTRATEPOTASSIUM CHLORIDE, POTASSIUM CHLORIOEPROCAINE HCL, PROCAINE HYDROCHLORIDEPYRIDOXINE HCL, PYRIDOXINE HYDROCHLORIDETHIAMINE HCL, THIAMINE HYDROCHLORIDEVIBISONE,-CYANOCOBALAMINIm-JOOn LABS/FORESTCORTISONE ACETATE, CORTISONE ACETATEDIPHENOXYLATE HCL AND ATROPINE SULFATE, ATROPINE SULFATEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCORTISONE, HYDROCORTISONEMETHOCARBAMOL, METHOCARBAMOLMETHYLTESTOSTERONE, METHYLTESTOSTERONEPHENDIMETRAZINE TARTRATE, PHEt.~IMETRAZINE TARTRATEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEIVES LAi9SI'A~!HOCERUBIDINE, DAUNORUBICIN HYDROCHLORIDESURMONTIL, TRIMIPRAMINE MALEATETRECATOR-SC, ETHIONAMIDE** J **JAconus PHA~MDAPSONE, DAPSONEJ~J~S!;F-~IPHAl"MIMODIUM, LOPERAMIDE HYDROCHLORIDEINAPSINE, DROPERIDOLWNOVAR, DROPERIDOLMONISTAT, MICONAZOLESL~LIMAZE, FENTANYL CITRATEVERMOX, MEBENDAZOLEJOHN 0 COPANOSAMOXICILLIN TRIHYDRATE, AMOXICILLIN TRIHYDRATEAMPICILLIN SODIUM, AMPICILLIN SODIUMAMPICILLIN TRIHYDRATE, AHPICILLIN/AMPICILLIN TRIHYDRATECOMOX, AHOXICILLINTRIHYDRATEPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPENICILLIN G PROCAINE, PENICILLIN G PROCAINEPENICILLIN V POTASSIUM, PENICILLIN V POTASSIUMSTREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE** K **KABI GROUP :meCRESCORMON, SOMATROPINKETCt!IJM LABSCHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECORTISONE ACETATE, CORTISONE ACETATEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCORTISONE, HYDROCORTISONEMEPROBAMATE, MEPROBAMATENITROFURANTOIN, NITROFURANTOINPREDNISOLONE, PREDNISOLONEPREDtHSOIIE, PREDNISOtIEQUINIDINE SULFATE, QUINIDINE SULFATERESERPINE, RESERPINESODIUM PENTOBARBITAL, PENTOBARBITAL SODIUMSODIUM SULFACETAMIDE, SULFACETAMIDE SODIUMTETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX19KEY ~HA~MSGENAPAX, GENTIAN VIOLETGUANIDINE HCl, GUANIDINE HYDROCHLORIDEQUINORA, QUINIDINE SULFATETHEO-DUR, THEOPHYllINETYZINE, TETRAHYDROZOlINE HYDROCHLORIDEKJ:J:!/(MAH LABSRAUWOLFIA SERPENTINA, RAlJWOlFIA SERPENTINARESINE, RESERPINEKNOLL PHARMAKINETON, BIPERIDEN HYDROCHLORIDEAKINETON lACTATE, BIPERIDEN lACTATEMEPERIDINE HCl, MEPERIDINE HYDROCHLORIDEPROMETHAZINE HCl, PRotlETHAZINE HYDROCHLORIDEVICODIN, ACETAMINOPHENKREMER5-U~BAHPRE-PEN, BENZYL PENICIllOYl-POlYlYSINEKV PHARMACEUT!CALCHlORPROtlAZINE HCl. CHLORPROMAZINE HYDROCHLORIDEDIPHENOXYlATE HCl WI ATROPINE SULFATE, ATROPINE SULFATEMEClIZINE HCl, MEClIZINE HYDROCHLORIDEMETHOCARBAMOl, METHOCARBAMOlPHENDnlETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATETHEOPHYllINE, THEOPHYllINE** l **lA!=AYETTE/ALCCHPANTOPAQUE, IOPHENDYLATELAHNF.TTACETAZOLAMIDE. ACETAZOLAMIDEAMINOPHYLLINE, AMINOPHYLLINEAQUEX, TRICHLORMETHIAlIDEBENZYL BENZOATE, BENZYL BENZOATEBETHANECHOL CHLORIDE, BETHANECHOL CHLORIDEBUTALAN, BUTABARBITAL SODIUMCORTISONE ACETATE, CORTISONE ACETATEDEXTROAMPHETAtlINE SULFATE, DEXTROAtfPHETAMINE SULFATEDIPHENHYDRAMINE HCL, DIPKENHYDRAMINE HYDROCHLORIDEDIPHENYLAN SODIUM, PHENYTOIN SODIUMFOLIC ACID, FOLIC ACIDFURAlAN, NITROFURANTOINGLUTETHIMIDE, GLUTETHIMIDEHYDROCORTISONE, HYDROCORTISONElANIAZID, ISONIAZIDLANOPHYLLIN, THEOPHYLLINELANTRISUL, TRISULFAPYRIMIDINESLAtrnETTlOFENE, ATROPINE SULFATEMEPROBAMATE, MEPROBAMATEMETHOCARBAtl0l, METHOCARBAMOlNEOMYCIN SULFATE, NEOMYCIN SULFATENITROFURAZONE, NITROFURAZONEPENTOBARBITAL SODIUM, PENTOBARBITAL SODIUMPHENETRON, CHlORPHENIRAMINE MALEATEPIPERAZINE CITRATE, PIPERAZINE CITRATEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPRIMIDOtlE, PRIMIDONEPROBAlAN, PROBENECIDPROCAINAMIDE HCl, PROCAINAHIDE HYDROCHLORIDEPROMETHAZINE HCl, PROMETHAZINE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATESECOBARBITAL SODIUM, SECOBARBITAL SODIUMSERPALAN, RESERPINESODIUM BUTABARBITAl, BUTABARBITAl SODIUMSODIUM P.A.S., SODIUM AHINOSAlICYLATESULFADIAZINE, SULFADIAZINESULFISOXAZOLE, SULFISOXAZOLETRIPELENNAMINE HCt. TRIPELENNAMINE HYDROCHLORIDEVElTANE, BROMPHENIRAMINE MALEATEVITAMIN D, ERGOCALCIFEROLLEDERLE LABS/AM CYAIIACETAMINOPHEN WI CODEINE, ACETAMINOPHENACHROHYCIN, TETRACYCLINE HYDROCHLORIDEACHROMYCIN V, TETRACYCLINE 'ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDEAMICAR, AMINOCAPRO,IC ACIDAMITRIPTYLINE HCl, AMITRIPTYLINE HYDROCHLORIDEAMPICIllIN. AMPICIllIN/AMPICIllIN TRIHYDRATEARISTOCORT, TRIAMCINOLONEARISTOCORT, TRIAMCItlOlONE ACETONIDEARISTOCORT, TRIAMCINOLONE DIACETATEARISTOCORT A, TRIAMCINOLONE ACETOHIDEARISTOGEl, TRIAMCINOLONE ACETONIDEARISTOSPAN, TRIAMCINOLONE HEXACETONIDEARTANE, TRIHEXYPHENIDYl HYDROCHLORIDEAUREotlYCIN, CHLORTETRACYCLINE HYDROCHLORIDECHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLOROTHIAZIDE, CHLOROTHIAZIDECHLORPHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATECHLORPROMAZINE HCL,CHLORPROMAZINE HYDROCHLORIDECYClOCORT, AMCINONIDEDECLOMYCIN, DEMECLOCYClINE HYDROCHLORIDEDEXAMETHASONE, DEXAMETHASONEDIAMOX, ACETAZOLAMIDE
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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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