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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021057
Company: ORGANON USA ORGANON

Products on NDA 021057

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	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021057

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
08/14/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021057Orig1s014,s017,s019,s021ltr.pdf
10/22/2020	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021057Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021057Orig1s020ltr.pdf
08/14/2023	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021057Orig1s014,s017,s019,s021ltr.pdf
08/14/2023	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021057Orig1s014,s017,s019,s021ltr.pdf
05/03/2016	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/14/2023	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021057Orig1s014,s017,s019,s021ltr.pdf
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.

Labels for NDA 021057

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf
08/14/2023	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf
08/14/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf
08/14/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf
08/14/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021057s014s017s019s021lbl.pdf
10/22/2020	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021057Orig1s020lbl.pdf
10/22/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021057Orig1s020lbl.pdf
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

Therapeutic Equivalents for NDA 021057

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

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