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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST72IODAHIDE HEGLUHINEINJECTABLE; INJECTIONRENOVUE-DIPER SQUIBB AND SONS 24Y.RENOVUE-65ER SQUIBB AND SONS 65Y.IODIPAHIDE HEGLUHINEINJECTABLE; INJECTIONCHOLOGRAFIN HEGLUHINEER SQUIBB AND SONS 10.3Y. * 52Y.IODIPAMIDE HEGLUHINE; *HULTIPlE*SEE DIATRIZOATE HEGLUMINEi IODIPAMIDE MEGLUMINEIODIPAMIDE SODIUMINJECTABLE; INJECTIONCHOLOGRAFIN SODIUMER SQUIBB AND SONS 207.IODOCHLORHYDROXYQUINi NYSTATINOINTMENT; TOPICALNYSTAFORMDOME LABS/MILES LABS 10MG/GM;100,OOO UNITS/GMIODOHIPPURATE SODIUM, 1-131INJECTABLE; INJECTIONHIPPURAN I 131HALLINCKRODTHIPPUTOPEER SQUIBB AND SONSIODOHIPPURATE SODIUHCIS RADIOPHARHSO.l-lHCI/VIALO.5-2MCI/VIALI 131O.5-lMCIIVIALIOPANOIC ACIDTABLET; ORALTELEPAQUEWINTHROP LISTER LINGIOPHENDYLATEINJECTABLE; INJECTIONPANTOPAQUELAFAYETTE/ALCONIOTHAlAHATE HEGlUHINEINJECTABLE; INJECTIONCONRAYHALLINCKRODTCONRAY-30HALLINCKRODTSOLUTION; URETHRALCYSTO-CONRAYHALLINCKRODTCYSTO-CONRAY IIMALLINCKRODT500HG100Y.60Y.30Y.43Y.17.27.IOTHALAHATE HEGLUHINEi IOTHALAHATE SODIUMINJECTABLE; INJECTIONVASCORAYMALLiNCKRODTIOTHALAMATE SODIUM527.;26Y.INJECTABLE; INJECTIONANGIO-CONRAYMALLINCKRODT 80Y.CONRAY-325MALLINCKRODT 54.37-CONRAY-400MAlLINCKRODT 66 •. 87.
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST73IOTHALAMATE SODIUM; *MULTIPLE*SEE IOTHALAMATE MEGLUMINE: IOTHALAMATE SODIUMIOTHALAMATE SODIUM, 1-125INJECTABLE: INJECTIONGLOFIL-125ABBOTT LABSIPODATE SODIUMCAPSULE; ORALORAGRAFIN SODIUMER SQUIBB AND SONSIRON DEXTRAN COMPLEX250-300 UCI/ML500MGINJECTABLE: INJECTIONIMFERONAP MERRELL-NATIONAL EQ 50MG IRON/i'lLIRON DEXTRANAP CARTER-GLOGAU LABS EQ SOMG IRON/I'llISOETHARINE HYDROCHLORIDESOLUTION; INHALATIONBROHKOSOlAN BREON LABS/STERLING O.ZSZ M 1ZISOETHARJ:HE HelAH DEY LABS 1ZANINT'L MEDICATION SYS O.ZSZ M 1Z0.0777. * 0.08337. * 0.17. * 0.1437. *0.1677. * 0.27.AH PARKE-DAVIS/w-L 1Z0.57.AH PHILIPS ROXANE LABS 1ZISOETHARINE MESYLATE0.1257.AEROSOL: INHALATIONBRONKOMETERBREON LABS/STERLING 0.617.ISOFLURANEGAS; INHALATIONFORANEOHIO MED PRODS/AIRCO 99.97.ISOF LUROPHATEOINTMENT; OPHTHALMICFLOROPRYLMERCK SHARP & DOHME 0.0257.ISONIAZIDINJECTABLE; INJECTIONHYDRAZIDAP ER SQUIBB AND SONS 100MG/MlRIMIJ"ONAP HOFFMANN-LA ROCHE ZOOMG/ZMl50MG/2MLSYRUP: ORALNYDRAZIDAA ER SQUIBB AND SONS SOMG/SMlRIMIFONAA HOFFMANN-LA ROCHE SOMG/SMlTABLET; ORALDOW-ISONIAZIDAA DOW PHARMS 300MGHYZYDAA MALLINCKRODT lOOMS M 300MGIHHAA CIBA PHARM 300MGISOHIAZIDAA ANABOLIC 100MGAA BARR LABS 100MG M 300MGAA BElL PHARMACAL 100MG .AA BOLAR PHARM lOOMS M ~AA CHELSEA LABS 100MG M 300MGAA DANBURY PHARMACAL SOMG M 100HS M 300MSAA ELI LILLY lOOMS It 300MGAA HALSEY DRUG SOMG M 100MG M 300MGAA MK LABS 100MG
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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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