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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Teva
Express Scripts
Colorcon
Accenture
Fish and Richardson
Argus Health
US Army
UBS

Generated: June 25, 2018

DrugPatentWatch Database Preview

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, Sandoz, and Teva, and is included in three NDAs. It is available from six 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 eleven 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 076684
Tradename:ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Applicant:Amphastar Pharm
Ingredient:enoxaparin sodium
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
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 N 0548-5601-00
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076684 ANDA Amphastar Pharmaceuticals, Inc. 0548-5602 N 0548-5602-00

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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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
Johnson and Johnson
UBS
Cerilliant
Cantor Fitzgerald
Fish and Richardson
Medtronic
Baxter

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