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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021197
Company: EMD SERONO INC

Products on NDA 021197

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CETROTIDE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	AP	Yes	Yes
CETROTIDE	CETRORELIX ACETATE	EQ 3MG BASE/VIAL	POWDER;SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2000	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21197ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-197_Cetrotide.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2023	SUPPL-29	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s029ltr.pdf
12/18/2023	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s017, s022ltr.pdf
12/22/2017	SUPPL-18	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021197Orig1s018ltr.pdf
12/18/2023	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s017, s022ltr.pdf
03/13/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/15/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/29/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/04/2008	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021197s010ltr.pdf
04/30/2004	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf
04/30/2004	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf
04/30/2004	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf
12/13/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021197

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf
12/18/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf
12/04/2023	SUPPL-29	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197Orig1s029lbl.pdf
04/04/2008	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf
08/11/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf

Therapeutic Equivalents for NDA 021197

CETROTIDE

POWDER;SUBCUTANEOUS; EQ 0.25MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	217776	QILU
CETRORELIX ACETATE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	No	AP	215737	TEVA PHARMS INC
CETROTIDE	CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	POWDER;SUBCUTANEOUS	Prescription	Yes	AP	021197	EMD SERONO INC

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