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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST40DEXTROSE; MANNITOLINJECTABLE; INJECTIONMANNITOL IO? WI DEXTROSE S? IN DISTILLED WATERAM MCGAW/AM HOSP SGM/IOOMLilOGM/IOOMLDEXTROSEi MANNITOL; SODIUM CHLORIDEINJECTABLEi INJECTIONMANNITOL IS? WI DEXTROSE S? IN SODIUM CHLORIDE O.4S?AM MCGAW/AM HOSP SGM/IOOMLilSGM/IOOMLi4S0MG/IOOMLMANNITOL S? W/ DEXTROSE S? IN SODIUM CHLORIDE O.12?AM MCGAW/AM HOSP SGM/IOOMLiSGM/IOOMLjl20MG/IOOMLDEXTROSE; POTASSIUM CHLORIDEINJECTABLEj INJECTIONDEXTROSE 5? AND POTASSIUM CHLORIDE O.075? IN PLASTIC. CONTAINERTRAVENOL LABS 5GM/IOOML;7SMG/IOOMLDEXTROSE 5? AND POTASSIUM CHLORIDE O.lS/. IH PLASTICCOHTAINERAP ABBOTT LABS 5GM/100ML;150MG/100MLAP TRAVENOL LABS 5GM/100ML;1~OMG/100MLDEXTROSE S? AND POTASSIUM CHLORIDE O.224? IN PLASTICCONTAINERTRAVENOL LABS SGM/IOOMLj224MG/IOOMLDEXTROSE 5/. AHD POTASSIUM CHLORJ:DE O.3/. IH PLASTICCOHTAIHERAP ABBOTT LABS 5GM/100ML;300MG/100MLAP TRAVENOL LABS 5GM/100ML;300MG/100ML.DEXTROSEi POTASSIUM CHLORIDE; SOOIUM CHLORIDE - IN PLASTICINJECTABLEj INJECTIONDEXTROSE 5?, SODIUM CHLORIDE O.2? AND POTASSIUM CHLORIDEO.07S?TRAVENOL LABS 5GM/IOOMLj 75MG/IOOMLi 200MG/IOOMLDEXTROSE 5?, SODIUM CHLORIDE O.2? AND POTASSIUM CHLORIDEO.IS?TRAVENOL LABS 5GM/IOOMLjISOMG/IOOMLj200MG/IOOMLDEXTROSE 5?, SODIUM CHLORIDE O.2? AND POTASSIUM CHLORIDEO.224?TRAVENOL LABS 5GM/IOOMLi224MG/IOOMLi200MG/IOOMLDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE - IN PLASTICINJECTABLEi INJECTIONDEXTROSE S?, SODIUM CHLORIDE O.2? AND POTASSIUM CHLORIDEO.3?TRAVENOL LABS 5GM/IOOMLi300MG/IOOMLi200MG/IOOMLDEXTROSE S?, SODIUM CHLORIDE O.225? AND POTASSIUM CHLORIDEO.15?ABBOTT LABS5GM/IOOMLiI50MG/IOOMLi22SMG/IOOMLDEXTROSE 5"/', SODIUM CHLORIDE O.45/. AHD POTASSIUM CHLORIDEO.15/.AP ABBOTT LABS 5GM/100ML;150MG/100ML;450MG/100MLAP TRAVENOL LABS 5GM/100ML;150MG/100ML;450MG/100MLDEXTROSE 5?, SODIUM CHLORIDE O.45? AHD POTASSIUM CHLORIDEO.ZZ4?AP ABBOTT LABS 5GM/100ML;ZZ4MG/100ML;450MG/100MLAP TRAVENOL LABS SGM/100ML;ZZ4MG/10DML;450MG/100MLDEXTROSE 5?, SODIUM CHLORIDE O.45? AHD POTASSIUM CHLORIDEO.3/.AP ABBOTT LABS 5GM/100ML;300MG/100ML;450MG/100MLAP TRAVENOL LABS 5GM/100ML;300MG/100ML;450MG/100MLDEXTROSE 5?, SODIUM CHLORIDE O.45? AND POTASSIUM CHLORIDEO.075?TRAVENOL LABSDEXTROSE; SODIUM CHLORIDE5GM/IOOMLi7SMG/IOOMLi450MG/IOOMLINJECTABLEi INJECTIONDEXTROSE IO? AND SODIUM CHLORIDE O.2? IN PLASTIC CONTAINERAM MCGAW/AM HOSP IOGM/IOOMLi200MG/IOOMLDEXTROSE IO? AND SODIUM CHLORIDE O.4S? IN PLASTIC CONTAINERAM MCGAW/AM HOSP IOGM/IOOMLi450MG/IOOMLDEXTROSE lO? AHD SODIUM CHLORIDE O.9? IH PLASTIC COHTAIHERAP AM MCGAW/AM HOSP lOGM/100ML;9DOMG/1DDMLAP TRAVENOL LABS lO.GM/100ML;900MG/10DMLDEXTROSE Z.5?' AHD SODIUM CHLORIDE O.45? IH PLASTICCOHTAIHERAP ABBOTT LABS Z.5GM/100ML;450MG/100MLAP AM MCGAW/AM HOSP Z.5GM/100ML;450MG/100MLAP TRAVENOL LABS Z.5GM/100ML;450MG/100MLDEXTROSE 2.5? AND SODIUM CHLORIDE O.9? IN PLASTIC CONTAINERAM ~lCGAW/AM HOSP 2 .5GM/IOOML; 900NG/IOOMLDEXTROSE 3.3? AND SODIUM CHLORIDE O.3? IN PLASTIC CONTAINERABBOTT LABS3.3GM/IOOMLi300MG/IOOMLDEXTROSE 5? AND SODIUM CHLORIDE O.ll? IN PLASTIC CONTAINERAM MCGAW/AM HOSP 5GM/IOOMLiIIOMG/IOOML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST~-._/41DEXTROSE; SODIUM CHLORIDEINJECTABLE; INJECTIONDEXTROSE 57. AND SODIUM CHLORrDE 0.27. rN PLASTrC CONTArNERAP AM MCGAW/AM HOSP SGM/IOOML;200MG/IOOMLAP CUTTER LABS SGM/IOOML;200MG/IOOMLAP TRAVENOL LABS SGM/IOOML;200MG/IOOMLDEXTROSE 57. AND SODIUM CHLORIDE O.225/. IN ,PLASTIC CONTAINERABBOTT LABS5GM/IOOML;225HG/IOOMLDEXTROSE 57. AND SODIUM CHLORIDE O.3/. IN PLASTIC CONTAINERABBOTT LAe·S5GM/IOOML; 300MG/IOOMLDEXTROSE 57. AND SOD rUM CHLORrDE 0.337. rH PLASTrc CONTArNERAP AM MCGAW/AM HOSP 5GM/IOOML;330MG/IOOMLAP TRAVENOL LABS SGM/IOOML;330MG/IOOMlDEXTROSE 57. AHD SOD rUM CHLORrDE 0.457. rN PLASTrc CONTArHERAP ABBOTT LABS SGM/IOOMl;4S0MG/100MLAP AM MCGAW/AN HOSP 5GM/IOOMl;4S0MG/IOOMLAP CUTTER LABS SGM/IOOML;4S0MG/IOOMLAP TRAVENOL LABS SGM/IOOML;4S0MS/IOOMLDEXTROSE S7. AHD SOD rUM CHLORZDE 0.97. XN PLASTIC COHTArHERAP ABBOTT LABS SGM/IOOML;900MG/IOONLAP AN NCGAW/AN HOSP SGM/IOOML;900MG/100MlAP TRAVENOL LABS 5GM/IOOML;900MG/IOOMlDEXTROSE 57. IN son rUM CHLORrDE 0.27. rH PlASTrc COHTAIHERAP TRAVENOL LABS SGM/IOOML;200NG/lOOMlDEXTRO~E 57. rN SODrUM CHLORrDE 0.337. IH PLASTrc CONTArNERAP TRAVENOL LABS SGM/IOONL;330MG/IOOMLDEXTROSE 57. IN sonIUM CHLORIDE 0.4S7. IN PLASTrc CONTAINERAP TRAVENOL LABS SGM/IOOML;4S0MG/IOOMLDEXTROSE S7. rN SOD rUM CHLORrDE 0.97. ZH PLASTrc CONTAINERAP TRAVENOL LABS SGM/IOOML;900MG/IOOMLDEXTROTHYROXINE SODIUNDIATRIZOATE NEGLUNINEINJECTABLE; INJECTIONHYPAQUEAP WINTHROP L/STERLING 30? M 60?REHO-t1-DZPAP ER SQUIBB AND SONS 307.REHO-t1-60AP ER SQUIBB AND SONS 607.SOLUTION; URETHRALCYSTOGRAFZHAT ER SQUIBB AND SONS 30?HYPAQUE-CYSTOAT WINTHROP L/STERLING 30?RENO-t1-30AT ER SQUIBB AND SONS 307.APAPDIATRIZOATE MEGLUNINEi DIATRIZOATE SODIUMINJECTABLE; INJECTIONHYPAQUE-MWINTHROP L/STERLINGHYPAQUE-76WINTHROP L/STERLINGRENOGRAFIN-60ER SQUIBB AND SONSREHOGRAFZH-76ER SQUIBB AND SONSRENOVISTER SQUIBB AND SONSRENOVIST IIER SQUIBB AND SONS507.i257. * 607.i307.66?;10?527.;87.66?;10?34. 37.i 357.28.57.i29.17.TABLET; ORALCHOLOXINTRAVENOL LABSING * 2NG * 4NG * 6NGSOLUTION; ORAL, RECTALGASTROGRAFINER SQUIBB AND SONS 667.;107.DIATRIZOATE MEGLUMINEDIATRIZOATE NEGLUMINEj IODIPANIDE NEGLUHINEINJECTABLE; INJECTIONCARDIOGRAFINER SQUIBB AND SONS 85/.DIATRIZOATE NEGLUNINEER SQUIBB AND SONS 767.SOLUTION; INTRAUTERINESINOGRAFINER SQUIBB AND SONS52.77.i26.87.
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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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PRESCRIPTION DRUG PRODUCTS DEEMED A
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