Details for New Drug Application (NDA): 211215
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The generic ingredient in ANGIOMAX RTU 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 211215
Tradename: | ANGIOMAX RTU |
Applicant: | Maia Pharms Inc |
Ingredient: | bivalirudin |
Patents: | 3 |
Pharmacology for NDA: 211215
Mechanism of Action | Thrombin Inhibitors |
Suppliers and Packaging for NDA: 211215
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215 | NDA | Endo USA, Inc. | 42023-622 | 42023-622-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |
ANGIOMAX RTU | bivalirudin | SOLUTION;INTRAVENOUS | 211215 | NDA | Endo USA, Inc. | 42023-622 | 42023-622-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 250MG/50ML (5MG/ML) | ||||
Approval Date: | Jul 25, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 20, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE AS AN ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 20, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE AS AN ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 20, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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