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Generated: November 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078990

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NDA 078990 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 078990
Tradename:ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Applicant:Apotex Inc
Ingredient:enoxaparin sodium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078990

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Sep 28, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Sep 28, 2018TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength60MG/0.6ML (100MG/ML)
Approval Date:Sep 28, 2018TE:APRLD:No

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