Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213879
Company: MSN LABORATORIES PRIVATE LTD
Company: MSN LABORATORIES PRIVATE LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 110MG BASE | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/21/2022 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |