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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 205660


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NDA 205660 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 205660
Pharmacology for NDA: 205660
Medical Subject Heading (MeSH) Categories for 205660
Suppliers and Packaging for NDA: 205660
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 205660 ANDA Sandoz Inc. 0781-3460 0781-3460-63 10 SYRINGE in 1 CARTON (0781-3460-63) / .3 mL in 1 SYRINGE (0781-3460-01)
ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 205660 ANDA Sandoz Inc. 0781-3482 0781-3482-63 10 SYRINGE in 1 CARTON (0781-3482-63) / .4 mL in 1 SYRINGE (0781-3482-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength30MG/0.3ML (100MG/ML)
Approval Date:Mar 15, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength40MG/0.4ML (100MG/ML)
Approval Date:Mar 15, 2023TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength60MG/0.6ML (100MG/ML)
Approval Date:Mar 15, 2023TE:APRLD:No

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