Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215503
Company: HIKMA PHARMS
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIRAGLUTIDE | LIRAGLUTIDE | 18MG/3ML(6MG/ML) | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 06/21/2024 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |