Direct Thrombin Inhibitor Drug Class List
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Drugs in Drug Class: Direct Thrombin Inhibitor
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Maia Pharms Inc | ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215-001 | Jul 25, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fresenius Kabi Usa | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 201811-001 | Mar 23, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 091665-001 | Jun 30, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
