← FDA DRUG APPROVALS

FDA BLA · BLA103471

BETASERON

interferon beta-1b

Sponsor: BAYER HEALTHCARE PHARMS

APPLICATION
BLA103471
TYPE
BLA
ORIGINAL APPROVAL
1993-07-23
LATEST ACTION
2024-05-09
ROUTE
SUBCUTANEOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

BETASERONPrescription
INTERFERON BETA-1B 0.3 MG · VIAL · SUBCUTANEOUS

Approval history

2024-05-09Labeling · Supplement 5203 · standard — Letter ↗AP
2023-07-28Labeling · Supplement 5202 · standard — Label ↗AP
2022-09-02Labeling · Supplement 5201 · standard — Letter ↗AP
2021-11-03Labeling · Supplement 5200 · standard — Letter ↗AP
2020-11-20Manufacturing (CMC) · Supplement 5199 — Letter ↗TA
2020-10-01Labeling · Supplement 5197 · standard — Letter ↗AP
2019-08-16Labeling · Supplement 5195 · standard — Letter ↗AP
2018-08-31Labeling · Supplement 5193 · standard — Label ↗AP
2018-06-08Labeling · Supplement 5191 · standard — Letter ↗AP
2017-05-26Efficacy · Supplement 5189 · standard — Letter ↗AP
2016-04-19Labeling · Supplement 5187 · standard — Label ↗AP
2016-04-19Labeling · Supplement 5157AP
2015-12-22Labeling · Supplement 5188 · standard — Label ↗AP
2015-09-25Efficacy · Supplement 5186 · standard — Label ↗AP
2014-01-28Labeling · Supplement 5185 · standard — Label ↗AP
2013-06-28Manufacturing (CMC) · Supplement 5125 — Label ↗AP
2012-12-11Labeling · Supplement 5079 — Label ↗AP
2012-12-11Labeling · Supplement 5067 — Label ↗AP
2012-12-11Labeling · Supplement 5138 · standard — Label ↗AP
2012-12-11Labeling · Supplement 5063 · standard — Label ↗AP
2012-12-11Labeling · Supplement 5136 · standard — Label ↗AP
2012-12-11Labeling · Supplement 5124 · standard — Label ↗AP
2012-12-11Labeling · Supplement 5088 — Label ↗AP
2012-12-11Labeling · Supplement 5120 · standard — Label ↗AP
2009-03-26Supplement · Supplement 5132AP
2008-09-08Supplement · Supplement 5121AP
2007-07-18Supplement · Supplement 5097AP
2007-04-26Supplement · Supplement 5084AP
2006-11-09Supplement · Supplement 5085AP
2006-10-20Efficacy · Supplement 5081 · standardAP
2006-04-04Supplement · Supplement 5082AP
2005-12-29Supplement · Supplement 5075AP
2005-12-29Supplement · Supplement 5071AP
2005-12-07Supplement · Supplement 5069AP
2005-07-28Supplement · Supplement 5065AP
2005-07-28Supplement · Supplement 5066AP
2005-06-08Supplement · Supplement 5060AP
2003-10-10Supplement · Supplement 5032 — Label ↗AP
2003-03-14Efficacy · Supplement 1039 · priority — Letter ↗AP
1993-07-23Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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