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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210857
Company: ZYDUS PHARMS USA INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOMILNACIPRAN LEVOMILNACIPRAN 20MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
LEVOMILNACIPRAN LEVOMILNACIPRAN 40MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
LEVOMILNACIPRAN LEVOMILNACIPRAN 80MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
LEVOMILNACIPRAN LEVOMILNACIPRAN 120MG CAPSULE, EXTENDED RELEASE;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
01/12/2023 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210857Orig1s000TAltr.pdf
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