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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210002
Company: INDOCO REMEDIES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOGLIPTIN ALOGLIPTIN BENZOATE 6.25MG TABLET;ORAL None (Tentative Approval) None No No
ALOGLIPTIN ALOGLIPTIN BENZOATE 12.5MG TABLET;ORAL None (Tentative Approval) None No No
ALOGLIPTIN ALOGLIPTIN BENZOATE 25MG 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
12/23/2019 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210002Orig1s000ltr.pdf
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