Details for New Drug Application (NDA): 208354
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NDA 208354 describes AMBRISENTAN, which is a drug marketed by Apotex, Aurobindo Pharma, Cipla, Endo Operations, Mylan, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, and Zydus Pharms, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the AMBRISENTAN profile page.
The generic ingredient in AMBRISENTAN is ambrisentan. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.
The generic ingredient in AMBRISENTAN is ambrisentan. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.
Summary for 208354
| Tradename: | AMBRISENTAN |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | ambrisentan |
| Patents: | 0 |
Pharmacology for NDA: 208354
| Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 208354
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMBRISENTAN | ambrisentan | TABLET;ORAL | 208354 | ANDA | Sigmapharm Laboratories, LLC | 42794-051 | 42794-051-08 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-08) |
| AMBRISENTAN | ambrisentan | TABLET;ORAL | 208354 | ANDA | Sigmapharm Laboratories, LLC | 42794-051 | 42794-051-22 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42794-051-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 10, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 10, 2019 | TE: | AB | RLD: | No | ||||
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