Data updated: Mar 10, 2026
HEPARIN SODIUM
HEPARIN SODIUM
Approved 1939-02-09
33
Indications
--
Phase 3 Trials
1
Priority Reviews
87
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1939-02-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
DELL LABS SAGENT PHARMS PLANO PHARMS SHENZHEN TECHDOW ASPEN GLOBAL INC Fresenius Kabi EMERGE BIOSCIENCE WATSON LABS INC Pfizer ABRAXIS PHARM Hikma SOLOPAK SMITH AND NEPHEW BE PHARMS PHARMACIA AND UPJOHN Dr. Reddy's EPIC PHARMA LLC CASI PHARMS INC Eli Lilly PHARMOBEDIENT B BRAUN MEDICAL CHAMBERLIN PARENTERL LUITPOLD PHARM SPEC GLAND PARKE DAVIS
Active Ingredient: HEPARIN SODIUM
Website: ↗
HEPARIN SODIUM Approval History
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What HEPARIN SODIUM Treats
33 FDA approvalsOriginally approved for its first indication in 1939 . Covers 33 distinct patient populations.
- Other (33)
Other
(33 approvals)- • Approved indication (Feb 1939)
- • Approved indication (Feb 1942)
- • Approved indication (May 1944)
- • Approved indication (Feb 1972)
- • Approved indication (Mar 1972)
- • Approved indication (May 1974) Priority
- • Approved indication (Nov 1974)
- • Approved indication (Dec 1975)
- • Approved indication (Feb 1978)
- • Approved indication (Apr 1978)
- • Approved indication (Dec 1978)
- • Approved indication (Apr 1983)
- • Approved indication (Dec 1983)
- • Approved indication (Jun 1984)
- • Approved indication (Jul 1985)
- • Approved indication (Apr 1986)
- • Approved indication (Oct 1995)
- • Approved indication (Jun 1996)
- • Approved indication (Jul 1996)
- • Approved indication (Aug 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Jun 2011)
- • Approved indication (Jul 2011)Label Letter
- • Approved indication (Jun 2014)
- • Approved indication (Jun 2016)Label Letter
- • Approved indication (Feb 2017)Letter
- • Approved indication (Nov 2017)Letter
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2018)
- • Approved indication (May 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Dec 2020)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HEPARIN SODIUM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.