Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211583
Company: TEVA PHARMS USA INC
Company: TEVA PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 2.5MG/1000MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 5MG/500MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 5MG/1000MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 10MG/500MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 10MG/1000MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
08/03/2022 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211583Orig1s000TA_ltr.pdf |