Details for New Drug Application (NDA): 211215
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NDA 211215 describes ANGIOMAX RTU, which is a drug marketed by Maia Pharms Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ANGIOMAX RTU profile page.
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.
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: | 11,903,993 | 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: | 11,918,622 | 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: | 11,992,514 | Patent Expiration: | May 20, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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