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.
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 29, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 7,589,106 | Patent Expiration: | Sep 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING THROMBOSIS | ||||||||
| Patent: | 7,687,516 | Patent Expiration: | Sep 26, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION | ||||||||
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