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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 Sagent Pharms, Hospira, Fresenius Kabi Usa, Pharma Serve Ny, Shenzhen Techdow, Watson Labs Inc, and Pfizer, and is included in eight NDAs. It is available from seven 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-five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

Summary for NDA: 089522

heparin sodium
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
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
INJECTABLE;INJECTION 089522 ANDA Cardinal Health 55154-2380 55154-2380-5 5 CARTRIDGE in 1 BAG (55154-2380-5) > .5 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/ML
Approval Date:May 4, 1987TE:RLD:Yes

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