Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206081
Company: SUN PHARM
Company: SUN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 500MG;EQ 5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 2.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | 1GM;EQ 5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206081Orig1s000TAltr.pdf |