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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST122SODIUM CHLORIDE; *MULTIPLE*SODIUM IODIDE, 1-123SEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDECAPSULE; ORALSEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMSODIUM IODIDE I 123CHLORIDE; SODIUM LACTATEMEDI-PHYSICS 100 UCISEE CALCIU~I CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDE" SOLUTION';C'.,ORA.L .....; ..SEE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM. SODIUM IODIDE \i~i23CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATEMED:I-PHYSICS2MCIIMLSEE CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDESEE CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE;SODIUM LACTATESODIUM IODIDE, 1-12SSEE DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUMACETATE; SODIUM CHLORIDESOLUTION; ORALSEE DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUMSODIUM IODIDE I 12SCHLORIDEMALLINCKRODT IMCI/VIALSEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUMLACTATESODIUM IODIDE, 1-131SEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDE; SODIUM GLUCONATECAPSULE; ORALSEE DEXTROSE; MANNITOL; SODIUM CHLORIDEIODOTOPESEE DEXTROSE; SODIUM CHLORIDEER"SQUIBB AND SONS 1-S0MCI * 8-S0 UCISEE MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;SODIUI1 IODIDE I 131SODIUM CHLORIDE; SODIUM GLUCONATECIS RADIOPHARMS 50 UCI * 100 UCISEE POTASSIUM CHLORIDE; SODIUM CHLORIDE MALLINCKRODT 0.7S-20MCI * 0.8-100MCI * lS-100 UCISEE POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINESOLUTION; ORALIODOTOPESODIUM CHRmlATE. CR-SlER SQUIBB AND SONS S-100MCI/BOTSODIUM IODID'E I 131INJECTABLE; INJECTIONCIS RADIOPHARMS 10 UCI-SOMCI/MLCHRO~IITOPE SODIUMMALLINCKRODT 3.S-lS0MCI/VIALER SQUIBB AND SONS 2S0 UCI/VIAL * IMCI/VIAL * 2MCI/VIALSODIUM CHROMATE CR SlMALLINCKRODT 100 UCI/MLSODIUM LACTATESODIUM GLUCONATE; *MULTIPLE*SEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDE; SODIUM GLUCONATESEE MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;SODIUM CHLORIDE; SODIUM GLUCONATEAPAPAPINJECTABLE; INJECTIONSODIUM LACTATE 0.167ABBOTT LABSAM MCGAW/AM HOSPTRAVENOL LABSSODIUM. LACTATE~MOLAR IH PLASTIC1.87GM/l00ML1.87GM/l00ML1.87GM/l00MLCOHTAIHER*MUL TIPLE*SEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE;POTASSIUf1 CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;SODIUM LACTATE~.
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST'-,--~-123SODIUM LACTATE; *MULTIPLE*SEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUMCHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE;SODIUM LACTATESEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUMLACTATESODIUM METRIZOATE; *MULTIPLE*SEE CALCIUM METRIZOATEi MAGNESIUM METRIZOATEi MEGLUHINEMETRIZOATEi SODIUM HETRIZOATESODIUM ROSE BENGAL, 1-131INJECTABLE; INJECTIONROBENGATOPEER SQUIBB AND SONSSODIUM ROSE BENGAL ICIS RADIOPHARMSHALLINCKRODT500131500100SODIUM SUCCINATE HEXAHYDRATEINJECTABLE; INJECTIONSODIUM SUCCINATEELKINS-SINN/AHROBINS 30XSODIUM TETRADECYL SULFATEUCI/VIAL * IHCI/VIAL * 2MCI/VIALUCIIMLUCI/MLSODIUM NITROPRUSSIDEINJECTABLE; INJECTIONNIPRIDEHOFFHANN-LA ROCHESOHG/VIALINJECTABLE; INJECTIONSOTRADECOLELKINS-SINN/AHROBINS IX * 3XSOMATROPIHSODIUM PERTECHNETATE, TC-99MSOLUTION; INJECTION, ORALSODIUM PERTECHNETATE TC 99MCIS RADIOPHARMSGAMMA DIAG LABS 10-60MCI/MLMEDI-PHYSICS 2-100MCI/MLSODIUM PHOSPHATE, P-3212MCI/ML * 24MCI/ML * 48MCI/MLSOLUTION; INJECTION, ORALPHOSPHOTOPEER SQUIBB AND SONS 1-10MCI/VIALSODIUM PHOSPHATE P 32HALLINCKRODT l-SMCI/VIAL * 1.SMCI/VIALSODIUM POLYSTYRENE SULFONATEINJECTABLE; INJECTIONASELLACRINSERONO LABS INCCRESCORMONKABI GROUP INCSORBITOL10 UNITS/VIAL4 UNITS/VIALSOLUTION; IRRIGATIONSORBITOL 3.3X IN PLASTIC CONTAINERAM MCGAW/AM HOSP 3.3GM/I00MLSORBITOL 3X IN PLASTIC CONTAINERTRAVENOL LABS 3GM/I00HLSORBITOL; *MULTIPLE*SEE MANNITOL; SORBITOLPOWDER; ORAL, RECTALKAYEXALATEBREON LABS/STERLING4S3.6GM/BOT
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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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-,----APPROVED PRESCRIPTION DRUG PR
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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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----..//APPROVED PRESCRIPTION DRUG
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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