Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205942
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | 2.5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | SAXAGLIPTIN;METFORMIN HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
01/21/2016 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205942Orig1s000TAltr.pdf |