Details for New Drug Application (NDA): 210701
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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 210701
Tradename: | AMBRISENTAN |
Applicant: | Apotex |
Ingredient: | ambrisentan |
Patents: | 0 |
Pharmacology for NDA: 210701
Mechanism of Action | Endothelin Receptor Antagonists |
Suppliers and Packaging for NDA: 210701
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMBRISENTAN | ambrisentan | TABLET;ORAL | 210701 | ANDA | Apotex Corp. | 60505-4552 | 60505-4552-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4552-3) |
AMBRISENTAN | ambrisentan | TABLET;ORAL | 210701 | ANDA | Apotex Corp. | 60505-4553 | 60505-4553-3 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4553-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 19, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 19, 2022 | TE: | AB | RLD: | No |
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