Details for New Drug Application (NDA): 212035
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NDA 212035 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 212035
| Tradename: | ARGATROBAN IN SODIUM CHLORIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | argatroban |
| Patents: | 0 |
Pharmacology for NDA: 212035
| Mechanism of Action | Thrombin Inhibitors |
Suppliers and Packaging for NDA: 212035
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | SOLUTION;INTRAVENOUS | 212035 | NDA | Accord Healthcare Inc. | 16729-430 | 16729-430-11 | 1 VIAL, SINGLE-USE in 1 CARTON (16729-430-11) / 50 mL in 1 VIAL, SINGLE-USE |
| ARGATROBAN IN SODIUM CHLORIDE | argatroban | SOLUTION;INTRAVENOUS | 212035 | NDA | Accord Healthcare Inc. | 16729-430 | 16729-430-43 | 10 VIAL, SINGLE-USE in 1 CARTON (16729-430-43) / 50 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/50ML (1MG/ML) | ||||
| Approval Date: | Jun 7, 2021 | TE: | RLD: | Yes | |||||
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