Details for New Drug Application (NDA): 211198
NDA 211198 describes MACITENTAN, which is a drug marketed by Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Laurus, Lepu Pharm, MSN, Mylan, Sun Pharm, Teva Pharms Usa Inc, Torrent, and Zydus Lifesciences, and is included in twelve NDAs. It is available from fourteen suppliers. Additional details are available on the MACITENTAN profile page.
The generic ingredient in MACITENTAN is macitentan. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the macitentan profile page.
The generic ingredient in MACITENTAN is macitentan. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the macitentan profile page.
Summary for 211198
| Tradename: | MACITENTAN |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | macitentan |
| Patents: | 0 |
Pharmacology for NDA: 211198
| Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 211198
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MACITENTAN | macitentan | TABLET;ORAL | 211198 | ANDA | Aurobindo Pharma Limited | 59651-147 | 59651-147-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-147-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 18, 2023 | TE: | AB | RLD: | No | ||||
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