Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215791
Company: CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.
Company: CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEGARELIX ACETATE | DEGARELIX ACETATE | 120MG | NJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | None (Tentative Approval) | None | No | No |
| DEGARELIX ACETATE | DEGARELIX ACETATE | 80MG | NJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 08/18/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |