Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217776
Company: QILU
Company: QILU
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
04/16/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CETRORELIX ACETATE
POWDER;SUBCUTANEOUS; EQ 0.25MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 218150 | GLAND |
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 214540 | LIVZON GRP |
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 217776 | QILU |
CETRORELIX ACETATE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | No | AP | 215737 | TEVA PHARMS INC |
CETROTIDE | CETRORELIX ACETATE | EQ 0.25MG BASE/VIAL | POWDER;SUBCUTANEOUS | Prescription | Yes | AP | 021197 | EMD SERONO INC |