Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211843
Company: MISSION PHARMACAL
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 |