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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022434

ARGATROBAN IN SODIUM CHLORIDE (ARGATROBAN)
50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ARGATROBAN
Proprietary Name: ARGATROBAN IN SODIUM CHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022434
Product Number: 001
Approval Date: Jun 29, 2011
Applicant Holder Full Name: CIPLA LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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