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

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APPROVED PRESCRIPTIOH DRUG PRODUCTSDRUG PRODUCT LIST98OXYTETRACYCLINE HYDROCHLORIDECAPSULE; ORALOXY-KESSO-TETRAAB MK LABSOXYTETRACYCLZHE HCLEQ 250MG BASEAB FEDERAL PHARMACAL E9 250MG BASEAB LEDERLE LABS/AM CYAN E9 250MG BASEAB PROTER LAB E9 250MG BASEAB PUREPAC PHARM E9 250MG BASEAB RICHLYN LABS E9 250MG BASEAB WEST-WARD § 250MG BASETERRAMYCIHAB PFIZER LABS E9 250MG BASEEQ 125HG BASEINJECTABLE; INJECTIONTERRAMYCINPFIZER LABS EQ 250MG BASE/VIAL *EQ SOOMG BASE/VIALOXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATEOINTMENT; OPHTHALMICTERRAMYCIN 101/ POLYMYXIN B SULFATEPFIZER LABSEQ 5HG BASE/GH;IO,OOO UNITS/GMOINTMENT; OTICTERRAMYCIN 101/ POLYMYXINPFIZER LABSEQ 5MG BASE/GM;IO,OOO UNITS/GHTABLET; VAGINALTERRAMYCIN-POLYMYXINPFIZER LABSEQ IOOMG BASE;IOO,OOO UNITSOXYTETRACYCLINE; *MULTIPLE*SEE LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINEOXYTOCININJECTABLE; INJECTIONIOXYTOCZHAP INVENEX LABS 10 UHUS/HLOXYTOCININJECTABLE; INJECTIONOXYTOCZHAP WYETH LABS/AMHOSYHTOCZHOHAP SANDOZ PHARMSLIQUID; NASALSYNTOCINONSANDOZ PHARHSPANCURONIUM BROMIDEINJECTABLE; INJECTIONPAVULONORGANON/AKZONAPARAMETHADIONECAPSULE; ORALPARADIONEABBOTT LABSCONCENTRATE; ORALPARADIONEABBOTT LABSPARAMETHASONE ACETATETABLET; ORALHALDRONEELI LILLYPARGYLINE HYOROCHLORIDETABLET; ORALEUTONYLABBOTT LABS10 UHUS/ML10 UHITS/ML40 UNITS/MLIMG/ML * 2MG/MLISOMG * 300MG300MG/MLIMG * 2MGIOMG * 2SHG * SONG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST,99PARGYLINE HYDROCHLORIDE; *MULTIPLE*SEE METHYCLOTHIAZIDEj PARGYLINE HYDROCHLORIDEPAROMOMYCIN SULFATECAPSULE; ORALHUMATINPARKE-DAVIS/W-LSYRUP; ORALHUMATINPARKE-DAVIS/W-LPEMOLINEEQ 250MG BASEEQ 125MG BASE/5MLPENICILLIN G BENZATHINEINJECTABLE; INJECTIONBICIlLIN L-AWYETH LABS/AMHOPERMAPENBC PFIZER LABSSUSPENSION; ORALBICIlLINWYETH LABS/AMHOTABLET; ORALBICIlLINWYETH LABS/AMHO300,000 UNITS/ML600,000 UNITS/ML300,000 UNITS/5ML200,000 UNITSTABLET; ORALCYLERTABBOTT LABSTABLET, CHEWABLE; ORALCYLERTABBOTT LABS18.75MG * 37.5MG * 75MG37.5MGPENICILLIN G BENZATHINE; PENICILLIN G PROCAINEINJECTABLE; INJECTIONBICIlLIN C-RWYETH LABS/AMHO150,000 UNITS/ML;150,000 UNITS/ML *300,000 UNITS/ML;300,000 UNITS/MLPENETATE CALCIUM TRISODIUM, YB-169INJECTABLE; INJECTIONYTTERBIUM YB 169 DTPADIAGNOSTIC PRODS/3MPENICILLAMINECAPSULE; ORALCUPRIMINEMERCK SHARP & DOHMETABLET; ORALDEPEN 250WALLACE LABS/C-WPENICILLIN G BENZATHINEINJECTABLE; INJECTIONBICIlLIN L-ABC WYETH LABS/AMHO2MCI/ML125MG * 250MG250MG600,000 UNITS/MLAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPAPPENICILLIN G POTASSIUMINJECTABLE; INJECTIONPEHZCZLLZH G POTASSZUMELI LILLYER SQUIBB AND SONSJOHN 0 COPANOSPARKE-DAVIS/W-LPFIZER LABSPFrlERPEHPFIZER LABS500,000 UHrTS/VZAL *1.000.000 UHZTS/VZAL *5.000,000 UHZTS/VZAL *20,000,000 UHZTS/VZAL200,000 UNITS/VIAL1,000,000 UHZTS/VZAL *5~000,000 UHZTS/VZAL *10,000.000 UHZTS/VZAL *20,000,000 UHZTS/VZAL500,000 UHZTS/VZAL *1,000,000 UHZTS/VIAL *5,000,000 UHZTS/VZAL *10,000.000 UHITS/VIAL1,000,000 UHITS/VZAL *5,000.000 UHZTS/VIAL20,000.000 UHITS/VIAL1,000,000 UHITS/VZAL *5,000,000 UHITS/VIAL *20,000,000 UHITS/VIAL
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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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j./APPROVED PRESCRIPTION DRUG PRODU
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-,----APPROVED PRESCRIPTION DRUG PR
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APPROVED PRESCRI~TIOHDRUG PRODUCTSD
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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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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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