Details for New Drug Application (NDA): 213512
✉ Email this page to a colleague
The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
Summary for 213512
Tradename: | BREXPIPRAZOLE |
Applicant: | Lupin Ltd |
Ingredient: | brexpiprazole |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Mar 17, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Mar 17, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Mar 17, 2023 | TE: | RLD: | No |
Complete Access Available with Subscription