← FDA DRUG APPROVALS

FDA BLA · BLA103949

PEGINTRON

Sponsor: SCHERING

APPLICATION
BLA103949
TYPE
BLA
ORIGINAL APPROVAL
2001-01-19
LATEST ACTION
2019-01-08
DOSAGE FORM
SYRINGE, VIAL
MARKETING STATUS
Prescription

Products

PEGINTRONPrescription
PEGINTERFERON ALFA-2B 120UG/0.5ML · SYRINGE
PEGINTRONPrescription
PEGINTERFERON ALFA-2B 80UG/0.5ML · SYRINGE
PEGINTRONPrescription
PEGINTERFERON ALFA-2B 150UG/0.5ML · VIAL
SYLATRONPrescription
PEGINTERFERON ALFA-2B 444 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL · VIAL
PEGINTRONPrescription
PEGINTERFERON ALFA-2B 80UG/0.5ML · VIAL
SYLATRONPrescription
PEGINTERFERON ALFA-2B 296 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL · VIAL
PEGINTRONPrescription
PEGINTERFERON ALFA-2B 150UG/0.5ML · SYRINGE
PEGINTRONPrescription
PEGINTERFERON ALFA-2B 50UG/0.5ML · SYRINGE
SYLATRONPrescription
PEGINTERFERON ALFA-2B 888 MCG LYOPHILIZED POWDER PER SINGLE-USE VIAL · VIAL
PEGINTRONPrescription
PEGINTERFERON ALFA-2B 120UG/0.5ML · VIAL
PEGINTRONPrescription
PEGINTERFERON ALFA-2B 50UG/0.5ML · VIAL

Approval history

2019-01-08Labeling · Supplement 5313 · standard — Label ↗AP
2018-12-21Labeling · Supplement 5312 · standard — Label ↗AP
2018-05-25Labeling · Supplement 5311 · standard — Letter ↗AP
2018-05-04Labeling · Supplement 5310 · standard — Letter ↗AP
2017-10-03Labeling · Supplement 5306 · standard — Label ↗AP
2017-10-02Labeling · Supplement 5307 · standard — Letter ↗AP
2017-10-02Labeling · Supplement 5305 · standard — Letter ↗AP
2017-05-25Labeling · Supplement 5304 · standard — Letter ↗AP
2015-09-16Labeling · Supplement 5299 · standard — Label ↗AP
2015-05-21Labeling · Supplement 5297 · standard — Label ↗AP
2015-05-13Labeling · Supplement 5298 · standard — Letter ↗AP
2014-11-17Labeling · Supplement 5293 · standard — Label ↗AP
2014-10-09Labeling · Supplement 5296 · standard — Letter ↗AP
2014-08-30Labeling · Supplement 5287 · standard — Label ↗AP
2014-08-14Labeling · Supplement 5285 · standard — Label ↗AP
2014-08-11Labeling · Supplement 5288 · standard — Label ↗AP
2014-07-31Labeling · Supplement 5295 · standard — Label ↗AP
2013-12-18Efficacy · Supplement 5259 · standard — Review ↗AP
2013-12-09Labeling · Supplement 5248 · standardAP
2013-11-15Labeling · Supplement 5273 · standard — Letter ↗AP
2013-05-15Labeling · Supplement 5263 · standard — Label ↗AP
2012-12-26Labeling · Supplement 5252 · standard — Label ↗AP
2012-07-02Labeling · Supplement 5232 · standard — Label ↗AP
2012-06-04Labeling · Supplement 5231 · standard — Letter ↗AP
2011-12-22Labeling · Supplement 5217 · standard — Label ↗AP
2011-12-22Labeling · Supplement 5222 · standard — Label ↗AP
2011-06-06Labeling · Supplement 5204 · standard — Letter ↗AP
2011-05-13Labeling · Supplement 5211 · standardAP
2011-05-06Labeling · Supplement 5203 · standardAP
2011-03-29Efficacy · Supplement 5153 · priority — Label ↗AP
2011-02-01Labeling · Supplement 5201 · standard — Letter ↗AP
2010-07-21Labeling · Supplement 5199 · standardAP
2010-01-26Labeling · Supplement 5184 · standardAP
2009-08-07Labeling · Supplement 5183 · standardAP
2009-05-08Efficacy · Supplement 5172 · standard — Label ↗AP
2009-05-08Labeling · Supplement 5175 · standard — Letter ↗AP
2009-03-10Efficacy · Supplement 5125 · standard — Label ↗AP
2008-12-11Efficacy · Supplement 5171 · priority — Pediatric Medical Review ↗AP
2008-12-11Supplement · Supplement 5174 — Label ↗AP
2008-03-26Efficacy · Supplement 5123 · standardAP
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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