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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST62HEPARIN SODIUMINJECTABLE; INJECTIONHEPARXH LOCK FLUSHAPINT'L MEDICATION SYS 10 UHXTS/ML500 UNITS/MLAP PARKE-DAVIS/W-L 10 UHiTS/MLHEPARXH SODXUMAP AH ROBINS 100 UHXTS/ML * 1,000 UHXTS/ML *AP5,000 UHXTS/ML * 10,000 UHXTS/MLAP AMERICAN BIOLOGICS 1,000 UHXTS/ML * 5,000 UHXTS/ML *AP 10,000 UHXTS/ML * 20,000 UHXTS/ML *AP ~O,OOO UHXTS/MLAP BEL-MAR LABS 1,000 UHXTS/ML * 5,000 UHXTS/ML *AP10,000 UHXTS/ML * 20,000 UHXTS/MLAP CARTER-GLOGAU LABS 100 UtlXTS/ML * 1,000 UHITS/ML *AP 5,000 UHXTS/ML * 10.000 UHXTS/ML *AP20.000 UHXTS/ML * 40,000 UHXTS/MLAP DELL LABS 1,000 UHXTS/ML * 5,000 UNXTS/ML *AP 10,000 UHXTS/ML * 20,000 UHXTS/ML *AP40,000 UHXTS/MLAP ELI LILLY 1,000 UHXTS/ML * 10.000 UHXTS/ML *AP20.000 UHXTS/MLAP ELKINS-SINN/AHROBINS 1,000 UHXTS/ML * 5,000 UHXTS/ML *AP 10.000 UHXTS/ML * 20.000 UHXTS/ML *AP40,000 UHXTS/ML250 UNITS/MLAP INOLEX CORP 1,000 UHXTS/ML * 5tOOO UHXTS/ML *AP10.000 UHXTS/MLAP INVENEX PHARMS/MOGUL 100 UHXTS/ML * 1,000 UHXTS/ML *APAP5,000 UIUTS/ML 10.000 UHXTS/MLLEDERLE LABS/AM CYAN 2,000 UHXTS/ML * 20,000 UHXTS/HLAP LYPHO-MED 1,000 UHXTS/ML * 5,000 UHXTS/ML *AP10,000 UHXTS/MLAP PARKE-DAVIS/W-L 1,000 UHXTS/ML StOOO UHXTS/ML *AP 7,500 UHXTS/ML * 10.000 UHXTS/ML *AP20,000 UHXTS/MLAP STERILAB/ABBOTT 10,000 UHXTS/MLAP TORIGIAN LABS 1,000 UHXTS/HLAP UPJOHN 1,000 UHXTS/ML * 5,000 UHXTS/ML *AP10,000 UHXTS/MLAP WYETH LABS/AMHO 1,000 UHXTS/ML * 2,500 UHXTS/ML AP 5,000 UHXTS/ML M 7,500 UHXTS/ML *AP 10,000 UNXTS/ML * 15,000 UHXTS/ML *AP20,000 UHITS/MLAPHEPARIH SODIUM IH HORMAL SALIHEWYETH LABS/AMHO 10 UNITS/ML * 100 UHITS/MLHEPARIN SODIUMINJECTABLE; INJECTIONHEPRIHARAP ARMOUR PHARMAPLIPO-HEPIHAP RIKER LABS/3MAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPLIQUAEMIHORGANON/AKZONAPAHHEPRIHABBOTT LABSSODIUM HEPARIHCARTER-GLOGAU LABSHETACILLINCORD LABSINVENEX LABSLYPHO-MEDMAURRY BIOLOGICALTRAVENOL LABS1,000 UHITS/ML * 5,000 UHITS/ML *10,000 UHITS/ML1,000 UHITS/ML *1,000 UNITS/500 UL *5,000 UHITS/ML * 10,000 UHITS/ML *5,000 UHITS/SOO UL 7,500 UHITS/500 UL *20.000 UHITS/ML M10,000 UHITS/SOO UL *40,000 UNXTS/ML15,000 UNITS/SOO UL1,000 UHITS/ML * 5,000 UHITS/ML *10,000 UHXTS/ML * 20,000 UHITS/ML *40,000 UHITS/ML10 UHXTS/ML * 1,000 UHITS/ML *5,000 UHITS/ML * 10,000 UHITS/ML *20,000 UHITS/ML * 40,000 UNITS/ML30 UNITS/ML2,500 UHITS/ML * 7,500 UHITS/ML3,000 UNITS/ML * 4,000 UNITS/ML *6,000 UNITS/ML1,000 UHITS/ML * 5,000 UHITS/ML *10,000 UHITS/ML * 20,000 UHITS/ML *40,000 UHITS/ML1,000 UtlITS/ML * 5,000 UHITS/ML *10,000 UHITS/ML * 20,000 UHITS/2ML1,000 UNITS/ML * 5,000 UHITS/ML *10,000 UNITS/ML * 20,000 UHITS/ML1,000 UNITS/ML M 5,000 UHITS/ML *10,000 UNITS/ML * 20,000 UNITS/ML *40,000 UHXTS/ML1,000 UNITS/MLPOWDER FOR RECONSTITUTION; ORALVERSAPENBRISTOL LABS IBM EQ 112.5MG AMPICILlML *EQ 112.5MG AMPICIL/5ML *EQ 225MG AMPICIL/5ML
'''"APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST63HETACILLIN POTASSIUMHEXACHLOROPHENECAPSULE; ORALSPONGE; TOPICALVERSAPEN-KSCRUBTEAM SURGI:AL SPONGEBRUSHBRISTOL LABS IBM EQ 450MG AMPICIL * EQ 225MG AMPICIL 3M 330MGHEXACHLOROPHENEAEROSOL; TOPICALSEPTISOLVESTAL LABS/CHEMED0.23?EMULSION; TOPICALHEXA-GERMAT HUNTINGTON LABS 3?-PHJ:SOHEXAT WINTHROP LISTER LING 3?-SOY-DOMEAT DOME L.ABS/MILES LABS 370WESCOHEXAT VITARINE/WEST CHEM 370AT WEST CHEM PRODS 370SOAP; TOPICALGAMOPHENARBROOK 2?SOLUTION; TOPICALDZALAT ARMOUR-DIAL/ARMOUR 0.2570GERMA-MEDICAHUNTINGTON LABS 1XGERMA-MEDZCA "MG"AT HUNTINGTON LABS 0.25?-SEPT:r-SOFTAT VESTAL LABS/CHEMED 0.2"570SEPT:rSOLAT VESTAL LABS/CHEMED 0.2570WESTASEPTWEST CHEM PRODS 0.4?SPONGE; TOPICALPHISO-SCRUBWINTHROP LISTER LING 3?PRE-OPDAVIS & GECK/AM CYAN 480MGHEXACHLOROPHENE; *MULTIPLE*SEE ALKYL AMMONIUM SULFONIC ACID BETAINE (SULFOBETAINE DEH)jAMMONIUM SALT OF C-12-C-15 LINEAR PRIMARY ALCOHOLETHOXYLATE; EDETATE SODIUM; ETHOMEEN C-25jHEXACHLOROPHENE; LANOLIN ALCOHOLS. ACETYLATEDHEXAFLUORENIUM BROMIDEINJECTABLE; INJECTIONMYLAXENWALLACE LABS/C-WHEXOCYCLIUM METHYLSULFATETABLET; ORALTRALABBOTT LABSHEXYLCAINE HYDROCHLORIDESOLUTION; TOPICALCYCLAINEMERCK SHARP & DOHME 57.HISTAMINE PHOSPHATEINJECTABLE; INJECTIONHISTAMINE PHOSPHATEELI LILLYVITARINE/WEST CHEMHOMATROPINE METHYLBROMIDE20MG/ML25MGTABLET; ORALHOMAPZH-10AA MISSION PHARMACAL 10MG275 UGM/ML * 550 UGM/ML * 2.75MG/ML1MG/ML
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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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oAPPROVED PRESCRIPTION DRUG PRODUCT
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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