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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021684
Company: EMD SERONO

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

Products on BLA 021684

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	300 IU/0.5ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	450 IU/0.75ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	900 IU/1.5ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
GONAL-F RFF REDI-JECT	FOLLITROPIN ALFA/BETA	150 IU/0.25ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021684

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2004	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21684_gonal-f_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21684ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021684s000_GonalTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2024	SUPPL-51	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021684s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021684Orig1s050, s051ltr.pdf
05/13/2024	SUPPL-50	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021684s050s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021684Orig1s050, s051ltr.pdf
11/06/2017	SUPPL-38	Supplement		Label is not available on this site.
10/16/2013	SUPPL-36	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf
04/04/2013	SUPPL-33	Supplement		Label is not available on this site.
02/19/2013	SUPPL-29	Supplement		Label is not available on this site.
02/14/2013	SUPPL-28	Supplement		Label is not available on this site.
02/08/2013	SUPPL-27	Supplement		Label is not available on this site.
01/31/2013	SUPPL-25	Supplement		Label is not available on this site.
01/23/2013	SUPPL-24	Supplement		Label is not available on this site.
02/06/2013	SUPPL-23	Supplement		Label is not available on this site.
01/11/2013	SUPPL-19	Supplement		Label is not available on this site.
12/06/2007	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s008ltr.pdf
12/18/2007	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021684s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s007ltr.pdf

Labels for BLA 021684

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2024	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021684s050s051lbl.pdf
05/13/2024	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021684s050s051lbl.pdf
05/13/2024	SUPPL-50	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021684s050s051lbl.pdf
10/16/2013	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf
12/18/2007	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021684s007lbl.pdf
05/25/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21684_gonal-f_lbl.pdf

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