← FDA DRUG APPROVALS

FDA BLA · BLA103234

PROCRIT

erythropoietin

Sponsor: AMGEN

APPLICATION
BLA103234
TYPE
BLA
ORIGINAL APPROVAL
1989-06-01
LATEST ACTION
2024-04-30
ROUTE
INTRAVENOUS, SUBCUTANEOUS, SINGLE-USE, MULTIDOSE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

EPOGEN/PROCRITPrescription
EPOETIN ALFA 40,000U/ML · VIAL · SINGLE-USE
EPOGEN/PROCRITPrescription
EPOETIN ALFA 2,000U/ML · VIAL · SINGLE-USE
EPOGEN/PROCRITPrescription
EPOETIN ALFA 20,000U/2ML · VIAL · MULTIDOSE
EPOGEN/PROCRITPrescription
EPOETIN ALFA 4,000U/ML · VIAL · SINGLE-USE
EPOGEN/PROCRITPrescription
EPOETIN ALFA 3,000U/ML · VIAL · SINGLE-USE
EPOGEN/PROCRITPrescription
EPOETIN ALFA 20,000/ML · VIAL · MULTIDOSE
EPOGEN/PROCRITPrescription
EPOETIN ALFA 10,000U/ML · VIAL · SINGLE-USE

Approval history

2024-04-30Labeling · Supplement 5378 · standard — Label ↗AP
2018-07-25Labeling · Supplement 5369 · standard — Letter ↗AP
2017-09-29Labeling · Supplement 5366 · standard — Label ↗AP
2017-09-29Labeling · Supplement 5363 · standard — Label ↗AP
2017-04-13Labeling · Supplement 5364 · standard — Label ↗AP
2017-04-13Labeling · Supplement 5360 · standard — Label ↗AP
2013-12-31Labeling · Supplement 5323 · standard — Label ↗AP
2013-03-27Labeling · Supplement 5329 · standard — Letter ↗AP
2012-05-31Labeling · Supplement 5281 · standard — Label ↗AP
2011-06-24Labeling · Supplement 5256 · standard — Letter ↗AP
2011-06-24Efficacy · Supplement 5166 · standard — Label ↗AP
2011-06-24Labeling · Supplement 5266 · standard — Label ↗AP
2010-02-16Labeling · Supplement 5199 · standard — Label ↗AP
2010-01-11Labeling · Supplement 5232 · standard — Label ↗AP
2009-10-13Labeling · Supplement 5221 · standard — Letter ↗AP
2008-11-19Supplement · Supplement 5196 — Label ↗AP
2008-11-19Labeling · Supplement 5195 · standard — Label ↗AP
2008-03-07Labeling · Supplement 5164 · standard — Label ↗AP
2007-12-17Labeling · Supplement 5163 · standard — Label ↗AP
2007-11-08Labeling · Supplement 5158 · standard — Label ↗AP
2007-03-09Labeling · Supplement 5122 · standard — Letter ↗AP
2006-05-11Labeling · Supplement 5104 · standard — Label ↗AP
2005-10-27Efficacy · Supplement 5082 · standardAP
2005-10-26Labeling · Supplement 5093 · standard — Label ↗AP
2004-11-10Labeling · Supplement 5076 · standard — Review ↗AP
2004-10-19Labeling · Supplement 1058 · standardAP
2004-06-30Efficacy · Supplement 5053 · standard — Label ↗AP
2004-05-21Efficacy · Supplement 5033 · standard — Review ↗AP
2003-05-07Labeling · Supplement 5034 · standardAP
2000-09-29Labeling · Supplement 1062 · standardAP
1999-07-26Supplement · Supplement 1046 — Label ↗AP
1996-12-23Efficacy · Supplement 1036 · unknownAP
1994-06-29Supplement · Supplement 1016AP
1993-04-01Efficacy · Supplement 1015 · unknown — Label ↗AP
1990-12-31Supplement · Supplement 1009AP
1989-06-01Type 1 - New Molecular Entity · Original · unknownAP
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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