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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214302
Company: ZYDUS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELEXIPAG SELEXIPAG 0.2MG TABLET;ORAL Discontinued None No No
SELEXIPAG SELEXIPAG 0.4MG TABLET;ORAL Discontinued None No No
SELEXIPAG SELEXIPAG 0.6MG TABLET;ORAL Discontinued None No No
SELEXIPAG SELEXIPAG 0.8MG TABLET;ORAL Discontinued None No No
SELEXIPAG SELEXIPAG 1MG TABLET;ORAL Discontinued None No No
SELEXIPAG SELEXIPAG 1.2MG TABLET;ORAL Discontinued None No No
SELEXIPAG SELEXIPAG 1.4MG TABLET;ORAL Discontinued None No No
SELEXIPAG SELEXIPAG 1.6MG 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
12/21/2022 ORIG-1 Approval STANDARD Letter (PDF)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214302Orig1s000TA_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214302Orig1s000ltr.pdf
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