Details for New Drug Application (NDA): 213981
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NDA 213981 describes BOSENTAN, which is a drug marketed by Natco Pharma Ltd, Zydus Pharms, Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Hikma, Mylan, Ph Health, Sun Pharm, and Watson Labs Inc, and is included in thirteen NDAs. It is available from five suppliers. Additional details are available on the BOSENTAN profile page.
The generic ingredient in BOSENTAN is bosentan. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bosentan profile page.
The generic ingredient in BOSENTAN is bosentan. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bosentan profile page.
Summary for 213981
| Tradename: | BOSENTAN |
| Applicant: | Zydus Pharms |
| Ingredient: | bosentan |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213981
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BOSENTAN | bosentan | TABLET, FOR SUSPENSION;ORAL | 213981 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1508 | 70710-1508-8 | 4 BLISTER PACK in 1 CARTON (70710-1508-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70710-1508-7) |
| BOSENTAN | bosentan | TABLET, FOR SUSPENSION;ORAL | 213981 | ANDA | Zydus Lifesciences Limited | 70771-1908 | 70771-1908-8 | 4 BLISTER PACK in 1 CARTON (70771-1908-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70771-1908-7) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 32MG | ||||
| Approval Date: | Feb 17, 2026 | TE: | AB | RLD: | No | ||||
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