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Generated: October 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076726

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NDA 076726 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 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 076726
Tradename:ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Applicant:Teva
Ingredient:enoxaparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076726
Medical Subject Heading (MeSH) Categories for 076726
Suppliers and Packaging for NDA: 076726
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076726 ANDA Teva Parenteral Medicines, Inc. 0703-8510 0703-8510-23 10 SYRINGE in 1 CARTON (0703-8510-23) > 1 mL in 1 SYRINGE (0703-8510-21)
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076726 ANDA Teva Parenteral Medicines, Inc. 0703-8530 0703-8530-23 10 SYRINGE in 1 CARTON (0703-8530-23) > .3 mL in 1 SYRINGE (0703-8530-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Jun 23, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Jun 23, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength60MG/0.6ML (100MG/ML)
Approval Date:Jun 23, 2014TE:APRLD:No

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