Rifampin Injectable Solution

Brand(s)
Rifadin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2014-06-12)
Oldest Current Product
1989-05-25
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\RIFAMPIN
FDAOB
INJECTION\INJECTION\RIFAMPIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\RIFAMPIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\RIFAMPIN

product(s) by strength(s)

rifampin 60 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000680597RifadinNDASanofi-Aventis U.S. Llc1989-05-25RIFAMPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA050627036ab68e-5085-4edc-bd83-784b43d64eab

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690112ANDAPfizer Labs2011-05-10RIFAMPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA065421b4d41487-b8f3-4f36-9144-f0e67a2ea53a
2000690141ANDAPfizer Labs2011-05-10RIFAMPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA06542150fb2618-cd9f-4f6a-a91f-5626f94d2f3b
3174780151ANDAAkorn2012-06-01RIFAMPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0655021881d0ef-38d3-4ecc-bd51-d20679b7dc2f
4231550340ANDAHeritage Pharmaceuticals Inc.2014-08-18RIFAMPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA2041016f03bb2a-1527-42c7-ab43-f4b4f789e69d
5633230351ANDAApp Pharmaceuticals, Llc2014-08-21RIFAMPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA091181a1f9f1e2-dfc0-4d31-a13b-b656d897b791
6674570445ANDAMylan Institutional Llc2008-05-23RIFAMPININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0654218be91604-d7cd-4f2b-997d-e3364e4092e5

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA064217RIFAMPINBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1999-10-29ANDA064217_001
2ANDA065421RIFAMPINMYLAN LABORATORIES LTD2008-05-22ANDA065421_001
3ANDA065502RIFAMPINVERSAPHARM INC2010-09-21ANDA065502_001
4ANDA091181RIFAMPINFRESENIUS KABI USA LLC2014-08-21ANDA091181_001
5ANDA204101RIFAMPINEMCURE PHARMACEUTICALS LTD2014-08-18ANDA204101_001
6NDA050627RIFADINSANOFI AVENTIS US LLC1989-05-25NDA050627_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA064217_001RXRIFAMPIN (600MG/VIAL)INJECTIONFalseAP1999-10-29RIFAMPIN
2ANDA065421_001RXRIFAMPIN (600MG/VIAL)INJECTIONFalseAP2008-05-22RIFAMPIN
3ANDA065502_001RXRIFAMPIN (600MG/VIAL)INJECTIONFalseAP2010-09-21RIFAMPIN
4ANDA091181_001RXRIFAMPIN (600MG/VIAL)INJECTIONFalseAP2014-08-21RIFAMPIN
5ANDA204101_001RXRIFAMPIN (600MG/VIAL)INJECTIONFalseAP2014-08-18RIFAMPIN
6NDA050627_001RXRIFAMPIN (600MG/VIAL)INJECTIONTrueAP1989-05-25RIFADIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1036ab68e-5085-4edc-bd83-784b43d64eab (view SPL)RIFADIN (rifampin capsules USP) and RIFADIN IV (rifampin for injection USP)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-06-129000680597, 000680508, 000680510Rifampin Oral Capsule
21881d0ef-38d3-4ecc-bd51-d20679b7dc2f (view SPL)RIFAMPIN FOR INJECTION USPprescriptionHuman PrescriptionAkorn2014-10-302174780151
350fb2618-cd9f-4f6a-a91f-5626f94d2f3b (view SPL)RIFAMPIN FOR INJECTION, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE2013-06-253000690141
46f03bb2a-1527-42c7-ab43-f4b4f789e69d (view SPL)prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-09-115231550340
58be91604-d7cd-4f2b-997d-e3364e4092e5 (view SPL)RIFAMPIN FOR INJECTION, USPRx OnlyprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-01-031674570445
6a1f9f1e2-dfc0-4d31-a13b-b656d897b791 (view SPL)Rifampin for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-08-251633230351
7b4d41487-b8f3-4f36-9144-f0e67a2ea53a (view SPL)RIFAMPIN FOR INJECTION, USPprescriptionHuman PrescriptionPfizer LabsANALYSIS, MANUFACTURE, PACK2013-06-256000690112

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