← FDA DRUG APPROVALS

FDA BLA · BLA103780

REBIF

interferon beta-1a

Sponsor: SERONO INC

APPLICATION
BLA103780
TYPE
BLA
ORIGINAL APPROVAL
2002-03-07
LATEST ACTION
2023-07-28
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SYRINGE
MARKETING STATUS
Prescription

Products

REBIFPrescription
INTERFERON BETA-1A 44UG/0.5ML · SYRINGE
REBIFPrescription
INTERFERON BETA-1A 22UG/0.5ML · SYRINGE

Approval history

2023-07-28Labeling · Supplement 5214 · standard — Label ↗AP
2021-11-03Labeling · Supplement 5210 · standard — Letter ↗AP
2020-05-26Labeling · Supplement 5207 · standard — Label ↗AP
2020-05-26Efficacy · Supplement 5203 · standard — Label ↗AP
2019-07-09Labeling · Supplement 5204 · standard — Letter ↗AP
2016-09-27Efficacy · Supplement 5196 · standard — Label ↗AP
2015-12-22Labeling · Supplement 5194 · standard — Label ↗AP
2015-03-10Labeling · Supplement 5172 · standard — Label ↗AP
2014-04-24Labeling · Supplement 5178 · standard — Label ↗AP
2014-04-24Labeling · Supplement 5179 · standard — Label ↗AP
2013-04-19Labeling · Supplement 5140 · standard — Label ↗AP
2012-12-21Manufacturing (CMC) · Supplement 5121 — Label ↗AP
2005-06-30Labeling · Supplement 5062 · standard — Label ↗AP
2004-12-23Labeling · Supplement 5030 · standard — Label ↗AP
2004-12-17Supplement · Supplement 5052 — Label ↗AP
2004-03-26Efficacy · Supplement 5027 · standardAP
2003-05-02Efficacy · Supplement 5010 · standard — Label ↗AP
2002-03-07Type 1 - New Molecular Entity · Original · unknown — 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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