isoniazid / Pyrazinamide / Rifampin Oral Tablet

Brand(s)
Rifater
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2013-04-19)
Oldest Current Product
1994-05-31
License(s)
NDA
RxNORM
ORAL TABLET\ISONIAZID:PYRAZINAMIDE:RIFAMPIN
FDAOB
ORAL\TABLET\ISONIAZID: PYRAZINAMIDE: RIFAMPIN
SPL Active
ORAL\TABLET, SUGAR COATED\ISONIAZID: PYRAZINAMIDE: RIFAMPIN
SPL Moiety
ORAL\TABLET, SUGAR COATED\ISONIAZID: PYRAZINAMIDE: RIFAMPIN

product(s) by strength(s)

isoniazid 50 mg / pyrazinamide 300 mg / rifampin 120 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000880576RifaterNDASanofi-Aventis U.S. Llc1994-05-31ISONIAZID, PYRAZINAMIDE, RIFAMPINORALTABLET, SUGAR COATEDNDA050705429a2f62-9fe6-4299-b314-92a9d22b1381

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490013RifaterNDARemedyrepack Inc.2010-09-15ISONIAZID, PYRAZINAMIDE, RIFAMPINORALTABLET, SUGAR COATED000880576NDA05070591e9be98-8d98-43c3-a1c0-0249b65d2744

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050705RIFATERSANOFI AVENTIS US LLC1994-05-31NDA050705_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA050705_001RXISONIAZID (50MG), PYRAZINAMIDE (300MG), RIFAMPIN (120MG)ORALTABLETTrue1994-05-31RIFATER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1429a2f62-9fe6-4299-b314-92a9d22b1381 (view SPL)RIFATER (rifampin, isoniazid and pyrazinamide USP)TabletsprescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-04-199000880576
291e9be98-8d98-43c3-a1c0-0249b65d2744 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-09-1526493490013

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII