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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021149
Company: EMD SERONO

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

Products on BLA 021149

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OVIDREL	CHORIOGONADOTROPIN ALFA	0.25MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
OVIDREL	CHORIOGONADOTROPIN ALFA	EQ 0.25MG /0.5ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021149

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/2000	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21149ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-149_Ovidrel.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/30/2015	SUPPL-40	Supplement		Label is not available on this site.
12/11/2014	SUPPL-39	Supplement		Label is not available on this site.
12/19/2013	SUPPL-37	Supplement		Label is not available on this site.
12/11/2013	SUPPL-36	Supplement		Label is not available on this site.
04/11/2013	SUPPL-35	Supplement		Label is not available on this site.
04/05/2013	SUPPL-34	Supplement		Label is not available on this site.
01/31/2013	SUPPL-33	Supplement		Label is not available on this site.
02/08/2013	SUPPL-32	Supplement		Label is not available on this site.
01/15/2013	SUPPL-31	Supplement		Label is not available on this site.
01/31/2013	SUPPL-30	Supplement		Label is not available on this site.
01/15/2013	SUPPL-29	Supplement		Label is not available on this site.
12/10/2012	SUPPL-26	Supplement		Label is not available on this site.
12/13/2012	SUPPL-25	Supplement		Label is not available on this site.
06/02/2010	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021149s020ltr.pdf
07/09/2013	SUPPL-17	Supplement		Label is not available on this site.
07/30/2007	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021149s013ltr.pdf
07/14/2003	SUPPL-6	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21149slr006ltr.pdf
05/15/2002	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 021149

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2010	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf
07/30/2007	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf
09/20/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf

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