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FDA Approval for GANIRELIX ACETATE issued to AMPHASTAR PHARMS INC

$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
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Abbreviated New Drug Application (ANDA): 212613
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
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