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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022434


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NDA 022434 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 022434
Tradename:ARGATROBAN IN SODIUM CHLORIDE
Applicant:Cipla
Ingredient:argatroban
Patents:2
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 29, 2011TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING THROMBOSIS
Patent:⤷  Try a TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION

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