Details for New Drug Application (NDA): 211224
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NDA 211224 describes MACITENTAN, which is a drug marketed by Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Laurus, MSN, Mylan, Seasons Biotech, Sun Pharm, Teva Pharms Usa Inc, Torrent, and Zydus Lifesciences, and is included in twelve NDAs. It is available from thirteen 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the macitentan profile page.
Summary for 211224
| Tradename: | MACITENTAN |
| Applicant: | Zydus Lifesciences |
| Ingredient: | macitentan |
| Patents: | 0 |
Pharmacology for NDA: 211224
| Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 211224
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MACITENTAN | macitentan | TABLET;ORAL | 211224 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1166 | 70710-1166-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1166-3) |
| MACITENTAN | macitentan | TABLET;ORAL | 211224 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1166 | 70710-1166-5 | 5 BLISTER PACK in 1 CARTON (70710-1166-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK (70710-1166-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 6, 2021 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Dec 3, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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