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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST126SULFAMETHOXAZOLETABLET; ORALGAHTAHOLAS HOFFMANN-LA ROCHEGAHTAHOL-OSAS HOFFMANN-LA ROCHESULFAMETHOXAZOLEAS BOLAR PHARMAS CORD LABSSOOMGlGMSULFAMETHOXAZOLE; TRIMETHOPRIMSUSPENSION; ORALBACTRJ:MAS HOFFMANN-LA ROCHESACTRJ:M PEOJ:ATRJ:CAS HOFFMANN-LA ROCHESEPTRAAS BURROUGHS WELLCOMETABLET; ORALSACTRJ:MAS HOFFMANN-LA ROCHESACTRIM OSAS HOFFtIANN-LA ROCHESEPTRAAS BURROUGHS WELLCOMESEPTRA OSAS BURROUGHS WELLCOMESULFAPHENAZOLESUSPENSION; ORALSULFABIDPURDUE FREDERICKTABLET; ORALSULFABIDPURDUE FREDERICKSULFAPYRIDINETABLET; ORALSULFAPYRIDINEELI LILLYSOOMG *' lGMSOOMG200MG/SMLl40MG/SML200MG/SMLl40MG/SML200MG/SMLl40MG/SML400MGl80MG800MG;!60MG400MG;80MG800MGll60MG500MG/5MLSOOMGSOOMGSULFASALAZINETABLET; ORALAZULFIDJ:HEAS PHARMACIA LABS SOOMGS.A.S.-SOOAS ROWELL LABSSOOMGSULFASALAZJ:HEBP BOLAR PHARM SOOMGBP CHELSEA LABS SOOMGAS LEDERLE LABS/AM CYAN SOOMGSULFATHIAZOLE; *MULTIPLE*SEE SULFABENZAMIDE; SULFACETAMIDE; SULFATHIAZOLE; UREASEE SULFABENZAMIDE; SULFACETAMIDE; SULFATHIAZOLESULFINPYRAZONECAPSULE; ORALANTURANECIBA PHARMTABLET; ORALANTURANECIBA PHARMSULFISOXAZOLE200MGIOOMGCREAM; VAGINALGAHTRJ:SJ:HAT HOFFMANN-LA ROCHE IOi!KORO-SULFAT HOLLAND-RANTOS IOi!TABLET; ORALGAHTRISIHAS HOFFMANN-LA ROCHE SOOMGSK-SOXAZOLEAS SKF LABS SOOMGSOSOLAS MK LABS SOOMGSTAHSIHAS STAN LABS PHARM SOOMG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST127SULFISOXAZOLETABLET; ORALSULFALARAD PARKE-DAVIS/W-L SOOMGSULFISOXAZOLEAD BARR LABS SOOMGBP CHELSEA LABS 500MGAD CORD LABS SOOMGAD HEATHER DRUG SOOMGAD ICN PHARMS SOOMGAD LANNETT SOOMGAD LEDERLE LABS/AM CYAN SOOMGAD MYLAN PHARMS SOOMGAD PHILIPS ROXANE LABS SOOMGAD RICHL YN L.A.BS SOOHGAD WEST-WARD SOOMGAD ZENITH LABS SOOMGSULSOXIHAB REID-PROVIDENT LABS SOOMGSULFISOXAZOLE DIOLAMINEOINTMENT; OPHTHALMICGANTRISINHOFFMANN-LA ROCHE4XSOLUTION/DROPS; OPHTHALMICGANTRISINHOFFMANN-LA ROCHE 4XSULFOXONE SODIUMTABLET, ENTERIC COATED; ORALDIASONE SODIUMABBOTT LABS165MGSULFUR; *MULTIPLE*SEE BENTONITE; SULFURSULFISOXAZOLE ACETYLEMULSION; ORALLIPO GANTRISINHOFFMANN-LA ROCHESUSPENSION; ORALGANTRISIN PEDIATRICHOFFMANN-LA ROCHESYRUP; ORALGANTRISINHOFFMANN-LA ROCHEEQ IGM BASE/5MLEQ 500MG BASE/5MLEQ 500MG BASE/5MLSULFISOXAZOLE ACETYL; *MUL TIPLE*SEE ERYTHROMYCIN ETHYLSUCCINATEj SULFISOXAZOLE ACETYLSULFISOXAZOLE DIOLAMINEINJECTABLE; INJECTIONGANTRISINHOFFMANN-LA ROCHE400MG/MLSULINDACTABLET; ORALCLINORILMERCK SHARP & DOHMESUTILAINSOINTMENT; TOPICALTRAVASETRAVENOL LABSTALBUTALTABLET; ORALLOTUS ATEWINTHROP LISTER LINGTAMOXIFEN CITRATETABLET; ORALNOLVADEXICI AMERICAS150MG * 200MG82.000 UNITS/GM120MGEQ 10MG BASE
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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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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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