Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214996
Company: MEITHEAL
Company: MEITHEAL
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 |
---|---|---|---|---|---|---|---|
06/06/2022 | 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 |
---|---|---|---|---|---|
03/20/2024 | SUPPL-2 | Labeling-Package Insert |
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 |
---|---|---|---|---|---|---|---|---|
FYREMADEL | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | Prescription | No | AP | 204246 | SUN PHARM |
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 | No | AP | 215658 | GLAND PHARMA LTD |
GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | Prescription | No | AP | 216075 | LUPIN LTD |
GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | Prescription | No | AP | 214996 | MEITHEAL |
GANIRELIX ACETATE | GANIRELIX ACETATE | 250MCG/0.5ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 021057 | ORGANON USA ORGANON |