Details for New Drug Application (NDA): 209324
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NDA 209324 describes BOSENTAN, which is a drug marketed by Alembic, Alvogen Pine Brook, Amneal Pharms Co, Chartwell Molecular, Endo Operations, Hikma, Mylan, Natco Pharma Ltd, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in eleven 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.
Suppliers and Packaging for NDA: 209324
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BOSENTAN | bosentan | TABLET;ORAL | 209324 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-038 | 47335-038-64 | 10 BLISTER PACK in 1 CARTON (47335-038-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK (47335-038-60) |
| BOSENTAN | bosentan | TABLET;ORAL | 209324 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-038 | 47335-038-86 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-038-86) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 62.5MG | ||||
| Approval Date: | Apr 26, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | Apr 26, 2019 | TE: | AB | RLD: | No | ||||
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