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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214935
Company: OPTIMUS PHARMA PRIVATE LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OBETICHOLIC ACID OBETICHOLIC ACID 5mg TABLET; ORAL None (Tentative Approval) None No No
OBETICHOLIC ACID OBETICHOLIC ACID 10mg 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
06/17/2022 ORIG-1 Tentative Approval STANDARD

Label is not available on this site.

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