Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217049
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | 5MG;2.5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | 10MG;5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | 12.5MG;2.5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | 25MG;5MG;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 |
---|---|---|---|---|---|---|---|
03/06/2024 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |