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Drugs@FDA: FDA-Approved Drugs

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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 AB 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
06/28/2019 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019569s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019569Orig1s006ltr.pdf
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/28/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019569s006lbl.pdf

THIOLA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOLA TIOPRONIN 100MG TABLET;ORAL Prescription Yes AB 019569 MISSION PHARMA
TIOPRONIN TIOPRONIN 100MG TABLET;ORAL Prescription No AB 216198 PAR PHARM INC
TIOPRONIN TIOPRONIN 100MG TABLET;ORAL Prescription No AB 214326 TEVA PHARMS USA INC
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