Details for New Drug Application (NDA): 210058
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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 210058
Tradename: | AMBRISENTAN |
Applicant: | Zydus Pharms |
Ingredient: | ambrisentan |
Patents: | 0 |
Pharmacology for NDA: 210058
Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 210058
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMBRISENTAN | ambrisentan | TABLET;ORAL | 210058 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1179 | 70710-1179-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1179-1) |
AMBRISENTAN | ambrisentan | TABLET;ORAL | 210058 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1179 | 70710-1179-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1179-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 28, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 28, 2019 | TE: | AB | RLD: | No |
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