Details for New Drug Application (NDA): 209509
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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 209509
Tradename: | AMBRISENTAN |
Applicant: | Endo Operations |
Ingredient: | ambrisentan |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 10, 2019 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 10, 2019 | TE: | RLD: | No |
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