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Generated: December 16, 2017

DrugPatentWatch Database Preview

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, Sandoz, and Teva, and is included in three 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 ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.

Summary for 077857

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
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)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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