Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213922
Company: ALEMBIC
Company: ALEMBIC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | 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 |
---|---|---|---|---|---|---|---|
03/03/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |