Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213654
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 5MG; 1GM | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 10MG; 1GM | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 12.5MG; 1GM | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | 25MG; 1GM | 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 |
---|---|---|---|---|---|---|---|
01/06/2021 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |