Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212338
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE || SITAGLIPTIN | 50MG | TABLET:FILM COATED | None (Tentative Approval) | None | No | No |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE || SITAGLIPTIN | 500MG | TABLET;FILM COATED | None (Tentative Approval) | None | No | No |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE || SITAGLIPTIN | 1000MG | TABLET;FILM COATED | 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 |
|---|---|---|---|---|---|---|---|
| 01/07/2025 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212338Orig1s000TAltr.pdf |