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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021211
Company: ORGANON USA INC

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

Products on BLA 021211

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOLLISTIM AQ	FOLLITROPIN ALFA/BETA	300 IU/0.36ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
FOLLISTIM AQ	FOLLITROPIN ALFA/BETA	600 IU/0.72ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
FOLLISTIM AQ	FOLLITROPIN ALFA/BETA	150 IU/0.18ML	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No
FOLLISTIM AQ	FOLLITROPIN ALFA/BETA	900 IU/1.08ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2004	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21211ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021211s000_FollistimTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2023	SUPPL-42	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021211Orig1s027;036;042ltr.pdf
02/07/2024	SUPPL-37	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021211s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021211Orig1s037ltr.pdf
03/21/2023	SUPPL-36	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021211Orig1s027;036;042ltr.pdf
03/21/2023	SUPPL-27	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021211Orig1s027;036;042ltr.pdf
12/15/2016	SUPPL-19	Supplement		Label is not available on this site.
11/15/2016	SUPPL-18	Supplement		Label is not available on this site.
11/09/2015	SUPPL-16	Supplement		Label is not available on this site.
08/22/2011	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021211s011ltr.pdf
06/28/2010	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021211s007ltr.pdf
02/11/2005	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21211s002ltr.pdf

Labels for BLA 021211

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2024	SUPPL-37	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021211s037lbl.pdf
03/21/2023	SUPPL-42	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf
03/21/2023	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf
03/21/2023	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf
03/21/2023	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf
03/21/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021211s027s036s042lbl.pdf
08/22/2011	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf
06/28/2010	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf
02/11/2005	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf
03/23/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf

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