FDA Approval for GANIRELIX ACETATE issued to AMPHASTAR PHARMS INC
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 212613
Company: AMPHASTAR PHARMS INC
Company: AMPHASTAR PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 04/07/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
GANIRELIX ACETATE
INJECTABLE;INJECTION; 250MCG/0.5ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | Prescription | No | AP | 212613 | AMPHASTAR PHARMS INC |
| GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 021057 | ORGANON USA INC |
| GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | Prescription | No | AP | 204246 | SUN PHARM |