Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216278
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIOPRONIN | TIOPRONIN | 300MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/15/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TIOPRONIN
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 | 216990 | TORRENT |