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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213782
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET;ORAL Discontinued None No No
BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET;ORAL Discontinued None No No
BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET;ORAL Discontinued None No No
BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET;ORAL Discontinued None No No
BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET;ORAL Discontinued None No No
BREXPIPRAZOLE BREXPIPRAZOLE 4MG 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
11/28/2023 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213782Orig1s000TAltr.pdf
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