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. Fifteen 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 |
Pharmacology for NDA: 020873
Mechanism of Action | Thrombin Inhibitors |
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 | Sandoz Inc | 0781-3158 | 0781-3158-95 | 10 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94) |
ANGIOMAX | bivalirudin | INJECTABLE;INTRAVENOUS | 020873 | NDA | Sandoz Inc | 0781-3447 | 0781-3447-95 | 10 VIAL, SINGLE-USE in 1 CARTON (0781-3447-95) / 1 INJECTION 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: | ⤷ Sign Up | Patent Expiration: | Jan 27, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | 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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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