Suppliers and packages for tradename: BIVALIRUDIN
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BIVALIRUDIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 206551 | ANDA | Accord Healthcare, Inc. | 16729-275-67 | 10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) / 5 mL in 1 VIAL, SINGLE-USE (16729-275-03) | 2018-11-07 |
| Dr Reddys | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 201577 | ANDA | Dr. Reddy's Laboratories Limited | 55111-652-37 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07) | 2017-05-31 |
| Eugia Pharma | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 205962 | ANDA | Eugia US LLC | 55150-210-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-210-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2018-07-27 |
| Fresenius Kabi Usa | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 090189 | ANDA | Fresenius Kabi USA, LLC | 63323-562-15 | 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41) | 2017-10-30 |
| Fresenius Kabi Usa | BIVALIRUDIN | bivalirudin | INJECTABLE;INTRAVENOUS | 090189 | ANDA | Fresenius Kabi USA, LLC | 63323-562-10 | 10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE | 2017-10-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
