interferon beta-1b Injection

Brand(s)
Betaseron, Extavia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2015-09-25)
Oldest Current Product
2009-08-14
License(s)
BLA
RxNORM
INJECTION\INTERFERON BETA-1B

product(s) by strength(s)

interferon beta-1b 0.3 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1000780569ExtaviaBLANovartis Pharmaceuticals Corporation2009-08-14INTERFERON BETA-1BKIT1252904cfdb571-ec4c-478f-bedc-e0669eeea504
2504190524BetaseronBayer Healthcare Pharmaceuticals Inc.INTERFERON BETA-1BKIT66311f74-0472-4fa3-848a-06002ca0def5

application(s)

#idtitleapprovedtradenamesfda division
1103471interferon beta-1b Application1993-07-23BetaseronCDER
2125290interferon beta-1b Application2009-08-14ExtaviaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1261fde67-efb2-4bd7-947e-4f68a56e76ff (view SPL)These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON.BETASERON (interferon beta-1b) for injection, for subcutaneous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2012-12-114504190523
24cfdb571-ec4c-478f-bedc-e0669eeea504 (view SPL)These highlights do not include all the information needed to use EXTAVIA safely and effectively. See full prescribing information for EXTAVIA. EXTAVIA (interferon beta-1b) for injection, for subcutaneous use Initial U.S. Approval: 1993prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2014-12-2211000780569
366311f74-0472-4fa3-848a-06002ca0def5 (view SPL)These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON.BETASERON (interferon beta-1b) for injection, for subcutaneous useInitial U.S. Approval: 1993prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE, PACK2015-09-253504190524

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