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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211843
Company: MISSION PHARMACAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOLA EC TIOPRONIN 100MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes No
THIOLA EC TIOPRONIN 300MG TABLET, DELAYED RELEASE;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
06/28/2019 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211843s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211843Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211843Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2021 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211843s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211843Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/08/2021 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211843s002lbl.pdf
06/28/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211843s000lbl.pdf

THIOLA EC

TABLET, DELAYED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOLA EC TIOPRONIN 100MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 211843 MISSION PHARMACAL
TIOPRONIN TIOPRONIN 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 217219 ENDO OPERATIONS
TIOPRONIN TIOPRONIN 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216456 TEVA PHARMS INC
TIOPRONIN TIOPRONIN 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216990 TORRENT

TABLET, DELAYED RELEASE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOLA EC TIOPRONIN 300MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 211843 MISSION PHARMACAL
TIOPRONIN TIOPRONIN 300MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216278 AMNEAL
TIOPRONIN TIOPRONIN 300MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 217219 ENDO OPERATIONS
TIOPRONIN TIOPRONIN 300MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216456 TEVA PHARMS INC
TIOPRONIN TIOPRONIN 300MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216990 TORRENT
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