Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207409
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ILOPERIDONE ILOPERIDONE 1MG TABLET;ORAL None (Tentative Approval) None No No
ILOPERIDONE ILOPERIDONE 2MG TABLET;ORAL None (Tentative Approval) None No No
ILOPERIDONE ILOPERIDONE 4MG TABLET;ORAL None (Tentative Approval) None No No
ILOPERIDONE ILOPERIDONE 6MG TABLET;ORAL None (Tentative Approval) None No No
ILOPERIDONE ILOPERIDONE 8MG TABLET;ORAL None (Tentative Approval) None No No
ILOPERIDONE ILOPERIDONE 10MG 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
07/02/2018 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207409Orig1s000TAltr.pdf

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