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Last Updated: June 18, 2024

Details for New Drug Application (NDA): 017029

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NDA 017029 describes HEPARIN SODIUM PRESERVATIVE FREE, which is a drug marketed by Dr Reddys, Fresenius Kabi Usa, Hospira, Nanjing King-friend, Pfizer, Pharma Serve Ny, Sagent Pharms, and Shenzhen Techdow, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the HEPARIN SODIUM PRESERVATIVE FREE profile page.

The generic ingredient in HEPARIN SODIUM PRESERVATIVE FREE is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 017029
Applicant:Fresenius Kabi Usa
Ingredient:heparin sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 017029
Suppliers and Packaging for NDA: 017029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 017029 NDA Henry Schein, Inc. 0404-9979 0404-9979-01 1 VIAL, MULTI-DOSE in 1 BAG (0404-9979-01) / 1 mL in 1 VIAL, MULTI-DOSE
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 017029 NDA HF Acquisition Co LLC, DBA HealthFirst 51662-1409 51662-1409-1 5 mL in 1 VIAL (51662-1409-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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