Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204246
Company: SUN PHARM
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
11/30/2018 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-1 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
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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