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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213660
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET;ORAL None (Tentative Approval) None No No
BREXPIPRAZOLE BREXPIPRAZOLE 4MG 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
09/08/2021 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213660Orig1s000TAltr.pdf
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