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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211972
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription BX 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
11/05/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ZILEUTON

There are no Therapeutic Equivalents.

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