Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017692
Company: ORGANON USA LLC

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

Products on BLA 17692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREGNYL	GONADOTROPIN, CHORIONIC	10,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Labels for BLA 017692

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2023	SUPPL-43	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023	SUPPL-36	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
03/02/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017692s028s036s043lbl.pdf
04/15/2011	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017692s021lbl.pdf
02/07/2007	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017692s018lbl.pdf