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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211224
Company: ZYDUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MACITENTAN MACITENTAN 10MG TABLET;ORAL Discontinued 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
04/06/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211224Orig1s000ltr.pdf
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