Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020378
Company: EMD SERONO

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

Products on BLA 20378

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GONAL-F	FOLLITROPIN ALFA/BETA	75 IU/VIAL	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No
GONAL-F	FOLLITROPIN ALFA/BETA	150 IU/VIAL	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No
GONAL-F	FOLLITROPIN ALFA/BETA	37.5 IU/VIAL	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No
GONAL-F	FOLLITROPIN ALFA/BETA	1,050 IU/VIAL	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
GONAL-F	FOLLITROPIN ALFA/BETA	450 IU/VIAL	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Labels for BLA 020378

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-84	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020378s084lbl.pdf
11/21/2023	SUPPL-84	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020378s084lbl.pdf
11/21/2023	SUPPL-84	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020378s084lbl.pdf
12/31/2020	SUPPL-75	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf
12/31/2020	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf
12/31/2020	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020378s045,s067,s075lbl.pdf
03/25/2004	SUPPL-15	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20378scf015_gonal_lbl.pdf
05/24/2000	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-378S-006_review.pdf