Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021057
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GANIRELIX ACETATE GANIRELIX ACETATE EQ 250MCG BASE/0.5ML INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21057ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21057_Antagon.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/12/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/19/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021057s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021057Orig1s010ltr.pdf
03/10/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/30/2008 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021057s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021057s007ltr.pdf
12/20/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/2001 SUPPL-2 Labeling

Label is not available on this site.

06/07/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021057s010lbl.pdf
06/30/2008 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021057s007lbl.pdf
07/29/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf

GANIRELIX ACETATE

INJECTABLE;INJECTION; EQ 250MCG BASE/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 EQ 250MCG BASE/0.5ML INJECTABLE;INJECTION Prescription Yes AP 021057 ORGANON USA INC
GANIRELIX ACETATE GANIRELIX ACETATE EQ 250MCG BASE/0.5ML INJECTABLE;INJECTION Prescription No AP 204246 SUN PHARM INDS LTD

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