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Generated: November 12, 2018

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Details for New Drug Application (NDA): 076684

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NDA 076684 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 076684
Tradename:ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Applicant:Amphastar Pharm
Ingredient:enoxaparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076684
Medical Subject Heading (MeSH) Categories for 076684
Suppliers and Packaging for NDA: 076684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684 ANDA Amphastar Pharmaceuticals, Inc. 0548-5601 0548-5601-00 10 SYRINGE in 1 CARTON (0548-5601-00) > .3 mL in 1 SYRINGE
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684 ANDA Amphastar Pharmaceuticals, Inc. 0548-5602 0548-5602-00 10 SYRINGE in 1 CARTON (0548-5602-00) > .4 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Sep 19, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Sep 19, 2011TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength60MG/0.6ML (100MG/ML)
Approval Date:Sep 19, 2011TE:APRLD:No

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