Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202461
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED 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 |
|---|---|---|---|---|---|---|---|
| 09/04/2018 | ORIG-1 | Tentative Approval |
Label is not available on this site. |