Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019569
Company: MISSION PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOLA TIOPRONIN 100MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/11/1988 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/15/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/01/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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