Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018730
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Discontinued None No No
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;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
05/04/1984 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/04/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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