Details for New Drug Application (NDA): 210386
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NDA 210386 describes CANAGLIFLOZIN, which is a drug marketed by Apotex and Aurobindo Pharma Ltd and is included in two NDAs. Additional details are available on the CANAGLIFLOZIN profile page.
The generic ingredient in CANAGLIFLOZIN is canagliflozin. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the canagliflozin profile page.
The generic ingredient in CANAGLIFLOZIN is canagliflozin. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the canagliflozin profile page.
Summary for 210386
| Tradename: | CANAGLIFLOZIN |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | canagliflozin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210386
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 20, 2026 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Apr 20, 2026 | TE: | RLD: | No | |||||
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