Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019569
Company: MISSION PHARMA
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 | 214326 | TEVA PHARMS USA INC |