Details for New Drug Application (NDA): 020873
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The generic ingredient in ANGIOMAX is bivalirudin. There are fourteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
Summary for 020873
| Tradename: | ANGIOMAX |
| Applicant: | Sandoz |
| Ingredient: | bivalirudin |
| Patents: | 2 |
Suppliers and Packaging for NDA: 020873
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873 | NDA AUTHORIZED GENERIC | Civica, Inc. | 72572-035 | 72572-035-10 | 10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01) |
| ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873 | NDA AUTHORIZED GENERIC | Pharma Packaging Solutions, LLC dba Tjoapack LLC | 75929-217 | 75929-217-01 | 10 VIAL, SINGLE-USE in 1 CARTON (75929-217-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/VIAL | ||||
| Approval Date: | Dec 15, 2000 | TE: | AP | RLD: | Yes | ||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 27, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Jan 27, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 020873
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873-001 | Dec 15, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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