← FDA DRUG APPROVALS

FDA NDA · NDA020287

FRAGMIN

dalteparin sodium

Sponsor: PFIZER

APPLICATION
NDA020287
TYPE
NDA
ORIGINAL APPROVAL
1994-12-22
LATEST ACTION
2024-10-24
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

FRAGMINDiscontinued
DALTEPARIN SODIUM 7,500 IU/0.75ML · INJECTABLE · INJECTION
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 95,000IU/3.8ML (25,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 10,000IU/4ML (2,500IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 10,000IU/ML (10,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 15,000IU/0.6ML (25,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMINDiscontinued
DALTEPARIN SODIUM 10,000IU/0.4ML (25,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 12,500IU/0.5ML (25,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMINDiscontinued
DALTEPARIN SODIUM 95,000IU/9.5ML (10,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 7,500IU/0.3ML (25,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 18,000IU/0.72ML (25,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 5,000IU/0.2ML (25,000IU/ML) · INJECTABLE · SUBCUTANEOUS
FRAGMIN · ReferencePrescription
DALTEPARIN SODIUM 2,500IU/0.2ML (12,500IU/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2024-10-24Labeling · Supplement 81 · standard — Label ↗AP
2024-10-15Efficacy · Supplement 80 · standard — Letter ↗AP
2020-12-05Labeling · Supplement 76 · standard — Letter ↗AP
2020-06-26Labeling · Supplement 74 · standard — Letter ↗AP
2020-06-26Labeling · Supplement 75 · standard — Letter ↗AP
2019-09-25Labeling · Supplement 60 · standardAP
2019-05-16Efficacy · Supplement 72 · priority — Label ↗AP
2017-05-12Labeling · Supplement 69 · standard — Label ↗AP
2017-01-26Manufacturing (CMC) · Supplement 68 · standardAP
2016-08-04Labeling · Supplement 67 · standard — Letter ↗AP
2015-09-29Labeling · Supplement 63 · standard — Letter ↗AP
2015-01-27Labeling · Supplement 62 · standard — Label ↗AP
2013-10-22Manufacturing (CMC) · Supplement 61 · standardAP
2013-09-27Manufacturing (CMC) · Supplement 59 · standardAP
2010-10-22Labeling · Supplement 50 · standard — Letter ↗AP
2009-12-23Labeling · Supplement 49 · standard — Letter ↗AP
2007-05-01Efficacy · Supplement 35 · unknown — Review ↗AP
2004-04-21Labeling · Supplement 34 · standard — Review ↗AP
2003-12-10Efficacy · Supplement 32 · standard — Review ↗AP
2003-06-30Labeling · Supplement 31 · standard — Review ↗AP
2003-02-27Labeling · Supplement 11 · standard — Letter ↗AP
2002-11-19Labeling · Supplement 29 · standard — Letter ↗AP
2002-11-01Labeling · Supplement 27 · standard — Letter ↗AP
2002-09-11Manufacturing (CMC) · Supplement 28 · standardAP
2002-04-26Manufacturing (CMC) · Supplement 26 · standardAP
2002-04-04Manufacturing (CMC) · Supplement 21 · standard — Letter ↗AP
2002-04-04Manufacturing (CMC) · Supplement 22 · standard — Letter ↗AP
2002-04-04Manufacturing (CMC) · Supplement 23 · standard — Letter ↗AP
2002-03-13Manufacturing (CMC) · Supplement 24 · standardAP
2001-09-04Manufacturing (CMC) · Supplement 20 · standardAP
2001-06-19Manufacturing (CMC) · Supplement 25 · standardAP
2000-11-14Manufacturing (CMC) · Supplement 17 · standard — Review ↗AP
2000-08-03Labeling · Supplement 18 · standard — Letter ↗AP
1999-08-05Manufacturing (CMC) · Supplement 15 · standard — Review ↗AP
1999-06-30Manufacturing (CMC) · Supplement 16 · standardAP
1999-05-25Efficacy · Supplement 10 · standard — Review ↗AP
1999-03-30Efficacy · Supplement 8 · standard — Review ↗AP
1999-01-22Manufacturing (CMC) · Supplement 12 · standardAP
1998-01-30Manufacturing (CMC) · Supplement 6 · standardAP
1998-01-30Labeling · Supplement 9 · 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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