← FDA DRUG APPROVALS

FDA BLA · BLA103132

INTRON A

Sponsor: SCHERING

APPLICATION
BLA103132
TYPE
BLA
ORIGINAL APPROVAL
1986-06-04
LATEST ACTION
2021-11-26
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

INTRON APrescription
INTERFERON ALFA-2B 25MIU/VIAL · VIAL
INTRON APrescription
INTERFERON ALFA-2B 10MIU/VIAL · VIAL
INTRON APrescription
INTERFERON ALFA-2B 18MIU/VIAL · VIAL

Approval history

2021-11-26Labeling · Supplement 5202 · standard — Letter ↗AP
2018-05-04Labeling · Supplement 5199 · standard — Letter ↗AP
2017-10-02Labeling · Supplement 5196 · standard — Letter ↗AP
2017-06-12Labeling · Supplement 5195 · standard — Label ↗AP
2015-05-21Labeling · Supplement 5191 · standard — Label ↗AP
2014-08-11Labeling · Supplement 5190 · standard — Label ↗AP
2014-04-02Labeling · Supplement 5183 · standard — Label ↗AP
2013-11-15Labeling · Supplement 5178 · standard — Label ↗AP
2012-06-04Labeling · Supplement 5163 · standard — Letter ↗AP
2011-12-20Labeling · Supplement 5161 · standard — Label ↗AP
2011-06-06Labeling · Supplement 5148 · standardAP
2011-05-13Labeling · Supplement 5153 · standardAP
2011-02-01Supplement · Supplement 5143 — Letter ↗AP
2010-07-21Labeling · Supplement 5140 · standardAP
2010-02-16Labeling · Supplement 5118 · standardAP
2009-08-07Labeling · Supplement 5122 · standardAP
2008-05-02Labeling · Supplement 5108 · standard — Letter ↗AP
2007-07-13Labeling · Supplement 5096 · standard — Letter ↗AP
2007-05-22Labeling · Supplement 5095 · standard — Label ↗AP
2007-05-22Supplement · Supplement 5059 — Letter ↗AP
2006-07-28Labeling · Supplement 5086 · standard — Label ↗AP
2004-10-27Supplement · Supplement 5064 — Letter ↗AP
2003-11-26Labeling · Supplement 5018 · standardAP
2002-06-21Labeling · Supplement 5022 · standardAP
2002-02-01Labeling · Supplement 5006 · standardAP
2001-11-29Labeling · Supplement 5009 · standardAP
2001-11-29Labeling · Supplement 5016 · standardAP
2001-06-21Efficacy · Supplement 1144 · standardAP
1998-08-18Efficacy · Supplement 1127 · standardAP
1997-11-06Efficacy · Supplement 1116 · priority — Review ↗AP
1997-04-29Supplement · Supplement 1120AP
1997-03-26Efficacy · Supplement 1107 · unknownAP
1995-12-05Efficacy · Supplement 1096 · unknownAP
1993-05-14Efficacy · Supplement 1040 · unknownAP
1992-07-13Efficacy · Supplement 1030 · unknownAP
1986-06-04Type 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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