Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210451
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CANAGLIFLOZIN | CANAGLIFLOZIN | 100mg | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| CANAGLIFLOZIN | CANAGLIFLOZIN | 300mg | TABLET; ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/21/2026 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210451Orig1s000ltr.pdf |