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FDA NDA · NDA201370

HEPARIN SODIUM

Sponsor: PFIZER

APPLICATION
NDA201370
TYPE
NDA
ORIGINAL APPROVAL
2011-07-21
LATEST ACTION
2025-09-24
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM PRESERVATIVE FREE · ReferencePrescription
HEPARIN SODIUM 1,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 5,000 UNITS/ML · INJECTABLE · INJECTION
HEPARIN SODIUM · ReferenceDiscontinued
HEPARIN SODIUM 10,000 UNITS/ML · INJECTABLE · INJECTION

Approval history

2025-09-24Labeling · Supplement 22 · standard — Letter ↗AP
2024-10-24Labeling · Supplement 21 · standard — Label ↗AP
2019-09-19Labeling · Supplement 14 · standard — Letter ↗AP
2019-09-19Labeling · Supplement 13 · standard — Letter ↗AP
2016-08-09Labeling · Supplement 10 · standard — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 8 · standardAP
2014-12-05Manufacturing (CMC) · Supplement 9 · standardAP
2014-04-22Labeling · Supplement 5 · standardAP
2014-04-22Labeling · Supplement 4 · standardAP
2012-12-11Labeling · Supplement 3 · standardAP
2011-07-21Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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