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Last Updated: June 14, 2021

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Details for New Drug Application (NDA): 208600


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NDA 208600 describes ENOXAPARIN SODIUM, which is a drug marketed by Amphastar Pharms Inc, Sandoz Inc, Amphastar Pharm, Apotex Inc, Nanjing King-friend, Sandoz, and Zydus Pharms, and is included in seven NDAs. It is available from two suppliers. Additional details are available on the ENOXAPARIN SODIUM profile page.

The generic ingredient in ENOXAPARIN SODIUM is enoxaparin sodium. There are thirteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.
Summary for 208600
Tradename:ENOXAPARIN SODIUM
Applicant:Amphastar Pharms Inc
Ingredient:enoxaparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208600
Medical Subject Heading (MeSH) Categories for 208600
Suppliers and Packaging for NDA: 208600
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENOXAPARIN SODIUM enoxaparin sodium INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 208600 ANDA Amphastar Pharmaceuticals, Inc. 0548-5608 0548-5608-00 1 VIAL in 1 CARTON (0548-5608-00) > 3 mL in 1 VIAL
ENOXAPARIN SODIUM enoxaparin sodium INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 208600 ANDA BluePoint Laboratories 68001-464 68001-464-41 1 VIAL in 1 CARTON (68001-464-41) > 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength300MG/3ML (100MG/ML)
Approval Date:Mar 14, 2019TE:ABRLD:No

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