Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214263
Company: ZYDUS PHARMS USA INC
Company: ZYDUS PHARMS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OSIMERTINIB MESYLATE | OSIMERTINIB MESYLATE | 40MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
OSIMERTINIB MESYLATE | OSIMERTINIB MESYLATE | 80MG | TABLET;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 |
---|---|---|---|---|---|---|---|
06/01/2021 | 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/2021/214263Orig1s000TAltr.pdf |