isoniazid / Rifampin Oral Capsule

Brand(s)
IsonaRif, Rifamate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2013-11-05)
Oldest Current Product
1975-07-11
License(s)
ANDA
RxNORM
ORAL CAPSULE\ISONIAZID:RIFAMPIN
FDAOB
ORAL\CAPSULE\ISONIAZID: RIFAMPIN
SPL Active
ORAL\CAPSULE\ISONIAZID: RIFAMPIN
SPL Moiety
ORAL\CAPSULE\ISONIAZID: RIFAMPIN

product(s) by strength(s)

isoniazid 150 mg / rifampin 300 mg oral capsule

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680509RifamateANDASanofi-Aventis U.S. Llc1975-07-11ISONIAZID, RIFAMPINORALCAPSULEANDA0618843cc36609-8e2d-4caa-a8e0-c0367e3e52df

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1617480017IsonaRifANDAVersapharm Incorporated2005-09-01ISONIAZID, RIFAMPINORALCAPSULEANDA0652211d3f27ec-1616-40fd-bc4f-91bb1744ceb0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA061884RIFAMATESANOFI AVENTIS US LLCANDA061884_001
2ANDA065221RIFAMPIN AND ISONIAZIDTrueHIKMA INTERNATIONAL PHARMACEUTICALS LLC2005-07-29ANDA065221_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA061884_001RXRIFAMPIN (300MG), ISONIAZID (150MG)ORALCAPSULETrueRIFAMATE
2ANDA065221_001discontinuedRIFAMPIN (300MG), ISONIAZID (150MG)ORALCAPSULEFalse2005-07-29RIFAMPIN AND ISONIAZID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11d3f27ec-1616-40fd-bc4f-91bb1744ceb0 (view SPL)IsonaRif (Rifampin and Isoniazid Capsules USP) 300 mg/150 mgprescriptionHuman PrescriptionVersapharm Incorporated2012-03-271617480017
23cc36609-8e2d-4caa-a8e0-c0367e3e52df (view SPL)RIFAMATE (rifampin and isoniazid capsules USP)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2013-11-053000680509

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