Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211731
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SILODOSIN | SILODOSIN | 4MG | CAPSULE;ORAL | Discontinued | None | No | No |
SILODOSIN | SILODOSIN | 8MG | CAPSULE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
11/22/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/02/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |