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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215017
Company: MSN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OBETICHOLIC ACID OBETICHOLIC ACID 5MG TABLET; ORAL Prescription None No No
OBETICHOLIC ACID OBETICHOLIC ACID 10MG TABLET; ORAL Prescription 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
12/15/2021 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215017Orig1s000TA_ltr.pdf
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