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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST138TRIPELENNAMINE CITRATEELIXIR; ORALpezGEIGY PHARMSTRIP[LENNAMINE HYDROCHLORIDETABLET; ORALPBZAA GEIGY PHARMS 50MG25MGTRIPELENNAMINE HClAA ANABOLIC 50MGAA BARR LABS 50MGAA BOLAR PHARM 50MGAA CHELSEA LABS 50MGAll DANBURY PHARMACAL 50MGAA GENERIC PHARM/IVY 50MGAll HEATHER DRUG 50MGAA LANNETT 50HGAA RICHLYN LABS 50MGAA TABLICAPS 50MGAA WEST-WARD 50MGEQ 25MG HCL/5MLTRISULFAPYRIMIDINESSUSPENSION; ORALHEOTR7ZIHEAB ELI LILLY 500MG/sMlgUAD-RAHOIDA8 PAUL B ELDER sOOMG/sMLSULFALOIDA8 OJF #2/CHROMALLOY sOOMG/SMLSULFOSEAB WYETH LABS/AMHO 500MG/SMLTERFOHYLA8 ER SQUIBB AND SONS SOOMG/SMlTRI-A-MULA8 FIRST TEXAS PHARMS SOOMG/SMLTRIPLE SULFAA8 NATL PHARM MFG/BARRE SOOMG/SNLABTRIPLE SULFASLEDERLE LABS/AM CYAN SOOMG/SMLTRIPLE SULFOIDA8 VALE CHEMICAL sOOHG/5HLTRISEMAB BEECHAM LABS SOOMG/sMLTRISUREIDAB REID-PROVIDENT LABS SOOMG/SMLTRIPROLIDINE HYDROCHLORIDESYRUP; ORALACTIDILAA BURROUGHS WELLCOME 1.ZSMG/SMlTRIPROLIDINE HCLAA NATL PHARM MFG/BARRE 1.ZSMG/5HLTABLET; ORALACTIDILAA BURROUGHS WELLCOMETRIPROLIDINE HCLAA BOLAR PHARMAA DANBURY PHARMACALAA LEMMON PHARMACALTRISULFAPYRIMIDINESSUSPENSION; ORALLANTRISULA8 LANNETTZ.SMGZ.5MGZ.5MGZ.SMG500MG/sMLABABABABABABABABABABTABLET; ORALNEOTRIZINEELI LILLYQUADETTSPAUL B ELDERSULFA-TRIPLE #ZRICHLYN LABSSULFALOIDSOOMG500MGSOONGOJF #2/CHROMALLOY 500MGSULFOSEWYETH LABS/AMHO ~TERFONYLER SQUIBB AND SONS SOOMGTRI-A-TABFIRST TEXAS PH ARMS ~TRIPLE SULFASTAN lABS PHARM 500MGTRIPLE SULFA #ZZENITH LABS500MGTRIPLE SULFASLEDERlE LABS/AM CYAN sOOMG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST139TRISULFAPYRIMIDINESTUBOCURARINE CHLORIDEABABTABLET; ORALTRIPLE SULFOIDVALE CHEMICALTRISEMBEECHAM LABS500MG500HGAPAPAPINJECTABLE; INJECTIONTUBOCURARIHE CHLORIDEABBOTT LABSELI LILLYER SQUIBB AND SONS!HG/ML!!MG/HL!HG/MLTROLEANDOMYCINCAPSULE; ORALTAOROERIG/PFIZERSUSPENSION; ORALTAOROERIG/PFIZERTROMETHAMINEINJECTABLE; INJECTIONTHAMABBOTT LABSEQ 2S0MG BASEEQ I25MG BASE/SML36MG/NLTROMETHAMINE; *MULTIPLE*SEE POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINETROPICAMIDESOLUTION/DROPS; OPHTHALMICMYDRIACYLALCON LABS o.s? * I?TRYPSINPOWDER; INHALATIONTRYPTARARMOUR PHARM2S0,000 UNITS/VIALTYBAMATECAPSULE; ORALTYBATRANAH ROBINSTYROPANOATE SODIUMCAPSULE; ORALBILOPAQUE SODIUMWINTHROP L/STERLING2S0MG * 3S0MG7S0MGUNDECOYLIUM CHLORIDE; UNDECOYLIUM CHLORIDE-IODINESOLUTION; TOPICALVIRAC REXCHESEBROUGH-PONDS o .S?;1 .8?UNDECOYLIUM CHLORIDE-IODINE; *MULTIPLE*SEE UNDECOYLIUM CHLORIDE; UNDECOYLIUM CHLORIDE-IODINEURACIL MUSTARDUREACAPSULE; ORALURACIL MUSTARDUPJOHNINJECTABLE; INJECTIONSTERILE UREAAP ABBOTT LABSIMG40GM/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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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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------"".,APPROVED PRESCRIPTION DRU
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APPROVED ¥RESCRIPTION DRUG PRODUCT
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'''"APPROVED PRESCRIPTION DRUG PROD
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----..//APPROVED PRESCRIPTION DRUG
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Page 119 and 120: APPROVED PRESCRIPTION DRUG PRODUCTS
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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