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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214646


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NDA 214646 describes ENOXAPARIN SODIUM (PRESERVATIVE FREE), which is a drug marketed by Amphastar Pharm, Be Pharms, Gland, Nanjing King-friend, Sandoz, Shenzhen Techdow, and Zydus Pharms, and is included in seven NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.
Summary for 214646
Tradename:ENOXAPARIN SODIUM (PRESERVATIVE FREE)
Applicant:Be Pharms
Ingredient:enoxaparin sodium
Patents:0
Pharmacology for NDA: 214646
Medical Subject Heading (MeSH) Categories for 214646
Suppliers and Packaging for NDA: 214646
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 214646 ANDA BE Pharmaceuticals Inc. 71839-109 71839-109-10 10 SYRINGE in 1 CARTON (71839-109-10) / .3 mL in 1 SYRINGE
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 214646 ANDA BE Pharmaceuticals Inc. 71839-110 71839-110-10 10 SYRINGE in 1 CARTON (71839-110-10) / .4 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Jun 6, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Jun 6, 2023TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength60MG/0.6ML (100MG/ML)
Approval Date:Jun 6, 2023TE:APRLD:No

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