Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208067
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
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 | 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 |
---|---|---|---|---|---|---|---|
01/21/2022 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208067Orig1s000TA_ltr.pdf |