Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217437
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | LEUPROLIDE ACETATE | 14MG/2.8ML (1MG/0.2ML) | SOLUTION;SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 06/09/2025 | 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 |
|---|---|---|---|---|---|
| 05/06/2026 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |