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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST56FERROUS SULFATE; FOLIC ACIDCAPSULE; ORALFOLVRONLEDERLE LABS/AM CYAN 182MG;330 UGMFLUMETHASONE PIVALATECREAM; TOPICALLOCORTENCIB.6. PHARM0.03?FIBRINOGEN, 1-125INJECTABLE; INJECTIONIBRINAMERSHAM/RADIOCHEMRADIONUCLIDE-LABELEDABBOTT LABS154 UCI/VIAL(125 I) FIBRINOGEN (HUMAN) SENSOR140 UCI/MLFIBRINOLYSIN; *MULTIPLE*SEE CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSINFLAVOXATE HYDROCHLORIDETABLET; ORALURISPASSKF LABSFLOXURIDINEINJECTABLE; INJECTIONFUDRHOFFMANN-LA ROCHEFLUCYTOSINECAPSULE; ORALANCOBONHOFFMANN-LA ROCHEFLUDROCORTISONE ACETATETABLET; ORALFLORINEFER SQUIBB AND SONS100MG500MG/VIAL250MG * 500MG100 UGMFLUOCINOLONE ACETONIDECREAM; TOPICALFLUOHIDAT MARION LABSSYHALARAT SYNTEX LABSSYNALAR-HPSYNTEX LABSSYHEMOLAT SYNTEX LABSGEL; TOPICALFLUOCINOLONE ACETONIDEALCON LABSOINTMENT; TOPICALFLUOHIDAT MARION LABSSYHALARAT SYNTEX LABSSOLUTION; TOPICALFLUOHIDAT MARION LABSSYHALARAT SYNTEX LABSFLUOCINONIDECREAM; TOPICALLIDEXAT SYNTEX LABSLIDEX-EAT SYNTEX LABSGEL; TOPICALTOPSYNSYNTEX LABS0.0170 M ~0.0170 M 0.025?0.02570~~o. oS'/.0.05?0.27-0.0257-0.0257-0.0257-0.057-
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST57FLUOCINONIDEOINTMENT; TOPICALLID EXS·YNTEX LABSFLUORESCEIN SODIUMINJECTABLE; INJECTIONFUNDUSCEIN-25SMITH MILLER PATCHO.05X25XFLUOXYMESTERONETABLET; ORALHALOTESTINBP UPJOHN2MG * 5~IGIO~IGORA-TESTRYLBP ER SQUIBB AND SONS 2MG * 5MGFLUOXYMESTERONE; *MULTIPLE*SEE ETHINYl ESTRADIOL; FLUOXYMESTERONEFLUOROMETHOLONECREAM; TOPICALOXYlONEUPJOHNO.025XSUSPENSION/DROPS; OPHTHALMICFMLALLERGAN PHARMS O.IXFLUOROURACILCREAM; TOPICALEFUDEXHOFFMANN-LA ROCHE 5XI FLUOROPLEXHERBERT LAB/ALLERGAN IXINJECTABLE; INJECTIONADRUC:rLAP ADRIA LABS~LUOROURAC:rLAP HOFFMANN-LA ROCHE50MG/ML50MG/MLSOLUTION; TOPICALEFUDEXHOFFMANN-LA ROCHE 2X * 5XFLUOROPLEXHERBERT LAB/ALLERGAN IXFLUPHENAZINE DECANOATEINJECTABLE; INJECTIONPROLIXIN DECANOATEER SQUIBB AND SONSFLUPHENAZINE ENANTHATEINJECTABLE; INJECTIONPROLIXIN ENANTHATEER SQUIBB AND SONSFLUPHENAZINE HYDROCHLORIDECONCENTRATE; ORALPERMITIlSCHERINGELIXIR; ORALPROLIXINER SQUIBB AND SONSINJECTABLE; INJECTIONPROLIXINER SQUIBB AND SONS25MG/ML25MG/ML5MG/ML2.5MG/5ML2.5MG/MLTABLET; ORALPERMITIlBP SCHERING 2.5MG * 5MG * IOMG250 UGM
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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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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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