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Generated: February 15, 2019

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Details for New Drug Application (NDA): 089522

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NDA 089522 describes HEPARIN SODIUM PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa, Hospira, Pfizer, Pharma Serve Ny, Sagent Pharms, Shenzhen Techdow, and Watson Labs Inc, and is included in eight NDAs. It is available from eight 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. Sixteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 089522
Tradename:HEPARIN SODIUM PRESERVATIVE FREE
Applicant:Hospira
Ingredient:heparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089522
Suppliers and Packaging for NDA: 089522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM PRESERVATIVE FREE heparin sodium INJECTABLE;INJECTION 089522 ANDA Hospira, Inc. 0409-1316 0409-1316-32 50 CARTRIDGE in 1 CONTAINER (0409-1316-32) > .5 mL in 1 CARTRIDGE (0409-1316-11)
HEPARIN SODIUM PRESERVATIVE FREE heparin sodium INJECTABLE;INJECTION 089522 ANDA Cardinal Health 55154-2380 55154-2380-5 5 CARTRIDGE in 1 BAG (55154-2380-5) > .5 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/ML
Approval Date:May 4, 1987TE:RLD:No

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