Details for New Drug Application (NDA): 091665
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NDA 091665 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Caplin, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Sandoz, Teva Pharms Usa, Cipla, Accord Hlthcare, and Eugia Pharma Speclts, and is included in sixteen NDAs. It is available from nine suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.
The generic ingredient in ARGATROBAN 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 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 091665
| Tradename: | ARGATROBAN |
| Applicant: | Endo Operations |
| Ingredient: | argatroban |
| Patents: | 0 |
Pharmacology for NDA: 091665
| Mechanism of Action | Thrombin Inhibitors |
Suppliers and Packaging for NDA: 091665
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARGATROBAN | argatroban | INJECTABLE;INJECTION | 091665 | ANDA | Endo USA, Inc. | 42023-182 | 42023-182-89 | 1 VIAL in 1 CARTON (42023-182-89) / 2.5 mL in 1 VIAL |
| ARGATROBAN | argatroban | INJECTABLE;INJECTION | 091665 | ANDA | Endo USA, Inc. | 42023-182 | 42023-182-01 | 1 VIAL in 1 CARTON (42023-182-01) / 2.5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/2.5ML (100MG/ML) | ||||
| Approval Date: | Jun 30, 2014 | TE: | AP | RLD: | No | ||||
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