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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021663
Company: FERRING

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 021663

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MENOPUR	MENOTROPINS (FSH;LH)	75 IU/VIAL;75 IU/VIAL	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021663

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2004	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21663lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21663ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-663_MenopurTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2016	SUPPL-26	Supplement		Label is not available on this site.
01/20/2015	SUPPL-21	Supplement		Label is not available on this site.
07/11/2014	SUPPL-19	Supplement		Label is not available on this site.
06/11/2013	SUPPL-16	Supplement		Label is not available on this site.
01/24/2013	SUPPL-15	Supplement		Label is not available on this site.
02/19/2014	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021663s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021663Orig1s014ltr.pdf
03/20/2006	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021663S001, 021663S00ltr.pdf
03/20/2006	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021663S001, 021663S00ltr.pdf

Labels for BLA 021663

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2014	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021663s014lbl.pdf
03/20/2006	SUPPL-2	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf
03/20/2006	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021663S001, 021663S002lbl.pdf
10/29/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21663lbl.pdf

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