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

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PRESCRIPTION DRUG PRODUCTS DEEMED APPROVEDPENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES4CURRENT STAniS - "EXEMPT" (COURT ORDER)DILAVAS #1 FERNDALE LABSPENTAERYTHRITOL TETRANITRATEDILAVAS #3 FERNDALE LABSPENTAERYTHRITOL TETRANITRATEDlr·IHANE AH ROBINSBROMPHENIRAMINE MALEATEDIMETANE EXPECTORANT AH ROBINSBROtlPHENIRAMINE MALEATE; GUAIFENESIN;PHENYLEPHRINE HYDROCHLORIDE;PHENYLPROPANOLAMINE HYDROCHLORIDEDIMHANE EXPECTORANT-DC AH ROBINSSRONPHENIRAMINE MALEATE; CODEINE PHOSPHATE; GUAIFENESIN;PHENYLEPHRINE HYDROCHLORIDE;PHENY LPROPANO LAtlINE HYDROCH LORIO EDIMETAPP AH ROBINSBROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE;PHENYLPROPANOLAMINE HYDROCHLORIDEDIPYRIDMIOLE BOLAR PHARMDIPYRIDAMOLEDIPYRIDAtlOLE CHELSEA LABSDIPYRIDAMOLEDIPYRIDAtlOLE PAR PHARMDIPYRIDAtl0LEDIPYRIDAtlOLE PHARMADYNE LABSDIPYRIDAtlOLEDIPYRIDAMOLE PREtlO PHARM LABSDIPYRIDAtlOLEDIPYRIDAtlOLE ZENITH LABSDIPYRIDAMOLEDISotlER SCHERINGDEXSROMPHENIRAMWE MALEATEDISOPHROL SCHERINGDEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATEDUOTRATE MARION LABSPENTAERYTHRITOL TETRANITRATEDUOTRATE 30 tlARION LABSPENTAERYTHRITOL TETRANITRATEDURABOLIN ORGANON/AKZONANANDROLONE PHENPROPIONATEDURABOLHI-50 ORGANON/AKZONANANDROLCNE PHENPROPIONATEDYSPAS SAVAGE/BYK-GULDENDICYCLOMINE HYDROCHLO~IDEENARAX 10 ROERIG/PFIZERHYDROXYZINE HYDROCHLORIDE; OXYPHENCYCLIMINE HYDROCHLORIDEENARAX 5 ROERIG/PFIZERHYDROXYZINE HYDROCHLORIDE; OXYPHENCYCLIMINE HYDROCHLORIDECURRENT STATUS - "EXEMPT" (COURT ORDER)FLORINEF-S ER SQUIBB AND SONSFLUDROCORTISONE HEMISUCCINATE; NEOMYCIN SULFATEFOLBESYN LEDERLE LABS/AM CYANASCORBIC ACID; FOLIC ACID; NIACINAMIDE;PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM PANTOTHENATE;THIAMINE HYDROCHLORIDEFORHISTAL CIBA PHARMDIMETHINDENE MALEATEHISPRIL SKF LABSDIPHENYLPYRALINE HYDROCHLORIDEHYCODAN BITARTRATE EI-IDO LABS/DUPONTHOMATROPINE tIETHYLBROMIDE; HYDROCODONE BITARTRATEILOTYCIN ELI LILLYERYTHROMYCINISOCHRON FOREST LABSISOSORBIOE DINITRATEISORDIL IVES LABS/AMHOISOSORBIDE DINITRATEISOROIL SUBLINGUAL IVES LABS/AMHOISOSORBIDE DINITRATEISORDIL TENBID IVES LABS/AMHOISOSORBIDE DINITRATEISOSORBIDE OINITRATE BARR LABSISOSORBIDE OINITRATEISOSORBIDE DINITRATE BOLAR PHARMISOSORBIOE DINITRATEISOSORBIDE DINITRATE CHELSEA LABSISOSORBIDE DINITRATEISOSORBIDE OINITRATE CORD LABSISOSORBIOE DINITRATEISOSORBIDE DINITRATE DANBURY PHARMACALISOSORBIDE OINITRATEISOSORBIDE OINITRATE LEDERLE LABS/AM CYANISOSORBIDE DINITRATEISOSORBIDE OINITRATE PAR PHARMISOSORBIDE DINITRATEISOSORBIDE DItHTRATE PUREPAC PHARMISOSORBIDE OINITRATEISOSORBIDE DINITRATE VITARINE/WEST CHEMISOSORBIDE OINITRATEISOSORBIDE OItlITRATEWEST-~AROISOSORBIDE DINITRATEISOSORBIDE DINITRATE ZENITH LABSISOSORBIDE OINITRATEKRYL AYERST LABS/AMHOASCORBIC ACID; ASPIRIN; ISOTHIPENDYL HYDROCHLORIDE;PHENACETIN; PHENYLEPHRINE HYIlROCHLORIDE
PRESCRIPTION DRUG PRObUCTS DEEMED APPROVEDPENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES5CURRENT STATUS - "EXEMPT" (COURT ORDER)LIBRAX HOFH1ANN-LA ROCHECHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDEM.V.I. USV PHARMASCORBIC ACID; DEXPANTHENOL; NIACINAMIDE;PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN;THIAMINE HYDROCHLORIDE; TOCOPHEROL, DL-ALPHA; VITAMIN A;VITAMIN DMARPLAN HOFFMANN-LA ROCHEISOCARBOXAZIDMEPROBAtlATE WI TRIDIHEXETHYL CHLORIDE CHELSEA LABSMEPROBAMATE; TRIDIHEXETHYL CHLORIDEMETAMINE PFIZER LABSTROLNITRATE PHOSPHATEMETI-DERM WI NEOMYCIN SCHERINGNEOMYCIN SULFATE; PREDNISOLONE~ETIMYD SCHERINGPREDNISOLONE ACETATE; SULFACETAMIDE SODIUMMILPATH-200 WALLACE PHARMS/C-W~IEPROBAMATE; TRIDIHEXETHYL CHLORIDEMILPATH-400 WALLACE PHARNS/C-14MEPROBAMATE; TRIDIHEXETHYL CHLORIDEMYCO TRIACET PREMO PHARM LABSGRAMICIDIN; NEOMYCIN SULFATE; NYSTATIN;TRIAMCINOLONE ACETONIDEMYCOLOG ER S~UIBB AND SONSGRAMICIDIN; NEOMYCIN SULFATE; NYSTATIN;TRIAMCINOLONE ACETONIDENEO-ARISTOCORT ACETONIDE LEDERLE LABS/AM CYANNEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDENEO-CORT-DOME DOME LABS/MILES LABSHYDROCORTISONE; NEOMYCIN SULFATENEO-CORTEF UPJOHNHYDROCORTISONE ACETATE; NEOMYCIN SULFATENEO-DELTA-CORTEF UPJOHNNEOMYCIN SULFATE; PREDNISOLONE ACETATENEO-DELTEF UPJOHNNEOMYCIN SULFATE; PREDNISOLONENEO-HYDEL TRASOL MERCK SHARP & DOH~IENEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATENEO-HYTONE DERMIK LABSIRORERHYDROCORTISONE; NEOMYCIN SULFATENEO-MEDROL UPJOHNMETHYLPREDNISOLONE; NEotlYCIN SULFATENEO-tIEDROL ACETATE UPJOHNMETHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATENEO-NYSTA~CORT DOME LABSIMILES LABSHYDROCORTISONE; NEOMYCIN SULFATE; NYSTATINCURRENT STATUS - "EXEMPT" (COURT ORDER)NEO-OXYLONE UPJOHNF LUORO~IETHOLONE; NEOMYCIN SULFATENEO-SYNALAR SYNTEX LABSFLUOCINOLONE ACETONIDE; NEOMYCIN SULFATENEODECADRON MERCK SHARP & DOHMEDEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATENEODECASPRAY MERCK SHARP & DOHMEDEXAMETHASONE; NEOMYCIN SULFATENEOMYCIN SULFATE-HYDROCORTISONE BIOCRAFT LABSHYDROCORTISONE; NEOMYCIN SULFATENEOMYCIN SULFATE-HYDROCORTISONE BYK-GULDENHYDROCORTISONE; NEOMYCIN SULFATENEOMYCIN SULFATE-HYDROCORTISONE ACETATE AMBIX LABSIORGANICSHYDROCORTISONE ACETATE; NEOMYCIN SULFATENEOMYCIN WI HYDROCORTISONE CLAY-PARK LABSHYDROCORTISOHE; NEOMYCIN SULFATENEOSONE UPJOHNCORTISONE ACETATE; NEOMYCIN SULFATENEOSPORIN BURROUGHS WELLCOMEBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATENEOSPORIN G BURROUGHS WELLCOMEGRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATENITRANITOL MERRELL-NATIONALMANNITOL HEXANITRATENITRETAMIN ER SQUIBB AND SONSTROLNITRATE PHOSPHATENITRETAMIN-IO ER SQUIBB AND SONSTROLNITRATE PHOSPHATENITRIN VALE CHEMICALPENTAERYTHRITOL TETRANITRATENITRO-BID MARION LABSNITROGLYCERINNITROGLYCERIN KV PHARMACEUTICALNITROGLYCERINNITROGLYN KEY PHARMSNITROGLYCERINNITROL KREMERS-URBANNITROGLYCERINNITRONG WHARTON LABSNITROGLYCERINNITROSPAN USV PHARMNITROGLYCERINNUNORPHAN ENDO LABSIDUPONTOXYHORPHONE HYDROCHLORIDENYSTAFORM-HC DOME LABS/MILES LABSHYDROCORTISONE; IODOCHLORHYDROXYQUIN; NYSTATINNYSTATIN NEOMYCIN GRAMICIDIN TRIAMCINOLONEE FOUGERAIBYK-GULDENGRAMICIDIN; NEOHYCIN SULFATE; NYSTATIN;TRIAMCINOLONE ACETONIDE
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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 PRESCRIPTION D
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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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