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

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APPROVED PRESCRIPTIOH DRUG PRODUCTSDRUG PRODUCT LIST38DEXAMETHASONE SODIUM PHOSPHATEINJECTABLE; INJECTIONHEXADROLAP ORGANON/AKlONAHEXADROL PHOSPHATEORGANON/AKlONAE9 4MG PHOSPHATE/MLEQ lONG PHOSPHATE/MLOINTMENT; OPHTHALMICDECADROHAT MERCK SHARP & DOHME EQ D.05? PHOSPHATEMAXIDEXAT ALCON LABS EQ D.05? PHOSPHATESOLUTION/DROPS; OPHTHALMICDECADRO'fAT MERCK SHARP & DOHME E9 D.l? PHOSPHATEDEXAMETHASOnE SODIUM PHOSPHATEAT BARNES-HIND PHARMS EQ D.l? PHOSPHATEAT MAURRY BIOLOGICAL E9 O.l? PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEj LIDOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONDECADRON WI XYLOCAINEMERCK SHARP & DOHMEDEXBROMPHENIRAMINE MALEATESYRUP; ORALDISOMERSCHERINGTABLET; ORALDISOMERSCHERINGEQ 4MG PHOSPHATE/ML;IOMG/ML2MG/SHL2MGDEXBROMPHENIRAMINE MALEATEj PSEUDOEPHEDRINE SULFATETABLET, CONTROLLED RELEASE; ORALDRIXORALSCHERING6MG;120MGDEXTROAMPHETAMINE ADIPATE; *MULTIPLE*SEE AMPHETAMINE ADIPATEj AMPHETAMINE SULFATEjDEXTROAtlPHETAMINE ADIPATEj DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE RESIN COMPLEX; *MULTIPLE*SEE AMPHETAMINE RESIN COMPLEXj DEXTROAMPHETAMINE RESIN, COMPLEXAAAAAAAAAAAAAAAAAAAAAAAADEXTROAMPHETAMINE SULFATECAPSULE, CONTROLLED RELEASE; ORALDEXEDRINESKF LABSSMG * IOMG * ISMGELIXIR; ORALDEXEDRINESKF LABSSMG/SMLTABLET; ORALDA-1DREXAR PHARMACAL lDMGDA-5REXAR PHARMACAL 5MGDEXAMPEXLEMMON PHARMACAL 5MG Jf 10MGDEXEDR:IHESKF LABS5MGDEXTROAMPHETAMIHE SULFATECORD LABS5MG Jf lOMGHALSEY DRUGLANNETTlOMG5MGJf lOMGISMGMM MAST SMGPUREPAC PHARMSMGSTANLABS PHARMSMGVITARINE/WEST CHEM SMG Jf lOMGFERHDEXFERNDALE LABS5MGDEXTROAMPHETAMINE SULFATE; *MULTIPLE*SEE AMPHETAMINE ADIPATEj AMPHETAMINE SULFATEjDEXTROAMPHETAMINE ADIPATEj DEXTROAMPHETAMINE SULFATE
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST·3cfDEXTROSEINJECTABLE; INJECTIONDEXTROSE 107. XH PLASTXC COHTAXHERAP AM MCGAW/AM HOSP 10GH/100HLAP TRAVENOLLABS 10GH/10UMLDEXTROSE 107. XH WATER XN PLASTIC CONTAIHERAP ABBOTT LABS 10GH/100NLDEXTROSE 2.57. IN PLASTIC CONTAINERAM MCGAW/AM HOSP 2.5GM/100MLDEXTROSE 207. IN PLASTIC CONTAINERTRAVENOL LABS 20GM/100MLDEXTROSE 307. IN PLASTIC CONTAINERTRAVENOL LABS 30GM/100MLDEXTROSE 407. IN PLASTIC CONTAINERTRAVENOL LABS 40GM/100MLDEXTROSE S7. XH PLASTIC COHTAIHERAP ABBOTT LABS SGM/100MLAPAPAM MCGAW/AM HOSPCUTTER LABSSGM/100MLSGH/100MLAP TRAVENOL LABS SSM/100MLDEXTROSE 507. IN PLASTIC CONTAINERTRAVENOL LABSDEXTROSE 607.50GM/100MLAM MCGAW/AM HOSP 60GM/100MLDEXTROSE; *MULTIPLE*SEE ALCOHOL; DEXTROSESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE;POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDEDEXTROSE; LIDOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONLXDOCAIHE HCL W/ DEXTROSEAP ABBOTT LABS 7.57.;57.DEXTROSE; LIDOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONXYLOCAINE HCL WI DEXTROSEASTRA PHARM PRODS 7.57.;1.57-XYLOCAIHE HCL W/ GLUCOSEAP ASTRA PHARM PRODS 7.S7.;S?DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE;SODIUM CHLORIDEINJECTABLE; INJECTIONPLASMA-LYTE 56 AND DEXTROSE 57- IN PLASTIC CONTAINERTRAVENOL LABS 5GM/100ML;32MG/100MLi128MG/100MLi234MG/100MLDEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDEINJECTABLEi INJECTIONNORMOSOL-M AND DEXTROSE 57- IN PLASTIC CONTAINERABBOTT LABS5GM/100MLi21MG/100ML;128MG/100MLi234MG/100MLDEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUMPHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE; INJECTIONDEXTROSE S? AND ELECTROLYTE HO.48 XH PLASTXC COHTAXHERAP TRAVENOL LABS SGH/100HL;31HG/100HL;141MG/IOOML;AP20MG/IOOML;12MG/100HL;260MG/100MLDEXTROSE S? W/ ELECTROLYTE 48 XH PLASTXC CONTAINERAP TRAVENOL LABS SGM/IOOHL;31MG/IOOHL;141MG/IOOML;AP20MG/100ML;12MG/IOOML;260MG/IOOHLDEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDE; SODIUM GLUCONATEINJECTABLE; INJECTIONNORMOSOL-R AND DEXTROSE .5% IN PLASTIC CONTAINERABBOTT LABS5GM/100MLi14MG/100ML;37MG/100ML;222MG/IOOMLi526MG/100MLi502MG/100MLPLASMA-LYTE 148 AND DEXTROSE 57- IN PLASTIC CONTAINERTRAVENOL LABS 5GM/100MLi30MG/100ML;37MG/100ML;368MG/100MLi526MG/100ML;502MG/100ML
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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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APPROVED PRESCRIPTION DRUG PRODUCTS
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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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