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Generated: November 17, 2018

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Details for New Drug Application (NDA): 077857

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NDA 077857 describes ENOXAPARIN SODIUM (PRESERVATIVE FREE), which is a drug marketed by Amphastar Pharm, Apotex Inc, Sandoz, and Teva, and is included in four NDAs. It is available from five suppliers. Additional details are available on the ENOXAPARIN SODIUM (PRESERVATIVE FREE) profile page.

The generic ingredient in ENOXAPARIN SODIUM (PRESERVATIVE FREE) is enoxaparin sodium. There are thirteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.
Summary for 077857
Tradename:ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Applicant:Sandoz
Ingredient:enoxaparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077857
Medical Subject Heading (MeSH) Categories for 077857
Suppliers and Packaging for NDA: 077857
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 077857 ANDA Sandoz Inc 0781-3133 0781-3133-63 10 SYRINGE in 1 CARTON (0781-3133-63) > .3 mL in 1 SYRINGE (0781-3133-01)
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 077857 ANDA Sandoz Inc 0781-3224 0781-3224-64 10 SYRINGE in 1 CARTON (0781-3224-64) > .4 mL in 1 SYRINGE (0781-3224-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength100MG/ML (100MG/ML)
Approval Date:Jul 23, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Jul 23, 2010TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Jul 23, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Daiichi Sankyo
Queensland Health
Express Scripts
Mallinckrodt
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Baxter
Johnson and Johnson

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