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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210213
Company: MSN LABS PVT LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOGLIPTIN ALOGLIPTIN BENZOATE EQ 6.25MG BASE TABLET;ORAL None (Tentative Approval) None No No
ALOGLIPTIN ALOGLIPTIN BENZOATE EQ 12.5MG BASE TABLET;ORAL None (Tentative Approval) None No No
ALOGLIPTIN ALOGLIPTIN BENZOATE EQ 25MG BASE 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
01/29/2019 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210213Orig1s000TAltr.pdf
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