Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207922
Company: BRECKENRIDGE PHARMS
Company: BRECKENRIDGE PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | 75MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | 110MG | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | 150MG | 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. |