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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 022485


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NDA 022485 describes ARGATROBAN IN SODIUM CHLORIDE, which is a drug marketed by Cipla, Gland Pharma Ltd, Sandoz, Accord Hlthcare, and Eugia Pharma Speclts, and is included in five NDAs. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the ARGATROBAN IN SODIUM CHLORIDE profile page.

The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE is argatroban. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 022485
Tradename:ARGATROBAN IN SODIUM CHLORIDE
Applicant:Sandoz
Ingredient:argatroban
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength125MG/125ML (1MG/ML)
Approval Date:May 9, 2011TE:APRLD:Yes

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