Details for New Drug Application (NDA): 216531
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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 216531
Tradename: | AMBRISENTAN |
Applicant: | Aurobindo Pharma |
Ingredient: | ambrisentan |
Patents: | 0 |
Pharmacology for NDA: 216531
Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 216531
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMBRISENTAN | ambrisentan | TABLET;ORAL | 216531 | ANDA | Aurobindo Pharma Limited | 59651-494 | 59651-494-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-494-30) |
AMBRISENTAN | ambrisentan | TABLET;ORAL | 216531 | ANDA | Aurobindo Pharma Limited | 59651-495 | 59651-495-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-495-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 21, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 21, 2022 | TE: | AB | RLD: | No |
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