Intron A

BLA 103132, held by Schering. Interferon Alfa-2b.

As of Nov 13, 2026, BLA 103132 (Intron A), held by Schering, was first approved by FDA on Jun 4, 1986, with 35 approved supplements and 0 published complete response letters.

First approved: Jun 4, 1986
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Jun 21, 2001	Supplement 1144Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 18, 1998	Supplement 1127Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 6, 1997	Supplement 1116Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Mar 26, 1997	Supplement 1107Efficacy (new indication or use)	Approved	None posted
Dec 5, 1995	Supplement 1096Efficacy (new indication or use)	Approved	None posted
May 14, 1993	Supplement 1040Efficacy (new indication or use)	Approved	None posted
Jul 13, 1992	Supplement 1030Efficacy (new indication or use)	Approved	None posted
Jun 4, 1986	Original applicationNew molecular entity	Approved	Review

Products

3 strengths and forms

Product	Active ingredient	Marketing
Intron A10MIU/VIAL · vial	Interferon Alfa-2b	Rx
Intron A18MIU/VIAL · vial	Interferon Alfa-2b	Rx
Intron A25MIU/VIAL · vial	Interferon Alfa-2b	Rx

All 36 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 26, 2021	Supplement 5202Labeling · Standard review	Approved	Label Letter
May 4, 2018	Supplement 5199Labeling · Standard review	Approved	Label Letter
Oct 2, 2017	Supplement 5196Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 12, 2017	Supplement 5195Labeling · Standard review	Approved	Label Letter
May 21, 2015	Supplement 5191Labeling · Standard review	Approved	Label Letter
Aug 11, 2014	Supplement 5190Labeling · Standard review	Approved	Label Letter
Apr 2, 2014	Supplement 5183Labeling · Standard review	Approved	Label
Nov 15, 2013	Supplement 5178Labeling · Standard review	Approved	Label Letter
Jun 4, 2012	Supplement 5163Labeling · Standard review	Approved	Letter
Dec 20, 2011	Supplement 5161Labeling · Standard review	Approved	Letter Label
Jun 6, 2011	Supplement 5148Labeling · Standard review	Approved	None posted
May 13, 2011	Supplement 5153Labeling · Standard review	Approved	None posted
Feb 1, 2011	Supplement 5143	Approved	Letter
Jul 21, 2010	Supplement 5140Labeling · Standard review	Approved	None posted
Feb 16, 2010	Supplement 5118Labeling · Standard review	Approved	None posted
Aug 7, 2009	Supplement 5122Labeling · Standard review	Approved	None posted
May 2, 2008	Supplement 5108Labeling · Standard review	Approved	Letter
Jul 13, 2007	Supplement 5096Labeling · Standard review	Approved	Letter Label
May 22, 2007	Supplement 5095Labeling · Standard review	Approved	Label Letter
May 22, 2007	Supplement 5059	Approved	Letter
Jul 28, 2006	Supplement 5086Labeling · Standard review	Approved	Label Letter
Oct 27, 2004	Supplement 5064	Approved	Letter Label
Nov 26, 2003	Supplement 5018Labeling · Standard review	Approved	None posted
Jun 21, 2002	Supplement 5022Labeling · Standard review	Approved	None posted
Feb 1, 2002	Supplement 5006Labeling · Standard review	Approved	None posted
Nov 29, 2001	Supplement 5016Labeling · Standard review	Approved	None posted
Nov 29, 2001	Supplement 5009Labeling · Standard review	Approved	None posted
Jun 21, 2001	Supplement 1144Efficacy (new indication or use) · Standard review	Approved	None posted
Aug 18, 1998	Supplement 1127Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 6, 1997	Supplement 1116Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Apr 29, 1997	Supplement 1120	Approved	None posted
Mar 26, 1997	Supplement 1107Efficacy (new indication or use)	Approved	None posted
Dec 5, 1995	Supplement 1096Efficacy (new indication or use)	Approved	None posted
May 14, 1993	Supplement 1040Efficacy (new indication or use)	Approved	None posted
Jul 13, 1992	Supplement 1030Efficacy (new indication or use)	Approved	None posted
Jun 4, 1986	Original applicationNew molecular entity	Approved	Review

Identifiers

Application: BLA 103132
Drugs@FDA: Overview at FDA
Company: Schering Corporation

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters