Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200624
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REPAGLINIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; REPAGLINIDE | 500MG;1MG | TABLET;ORAL | Discontinued | None | No | No |
| REPAGLINIDE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; REPAGLINIDE | 500MG;2MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/15/2015 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200624Orig1s000ltr.pdf |