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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020582
Company: ORGANON USA INC

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

Products on BLA 020582

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOLLISTIM	FOLLITROPIN ALFA/BETA	75 IU/VIAL	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No
FOLLISTIM	FOLLITROPIN ALFA/BETA	150 IU/VIAL	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 020582

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1997	ORIG-1	Approval		N/A	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20582_FOLLISTIM%2075IU%20AND%20150IU%20VIALS_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020582_follistim_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2002	SUPPL-8	Supplement		Label is not available on this site.
07/05/2002	SUPPL-7	Supplement		Label is not available on this site.
02/26/2002	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20582s6ltr.pdf
05/25/2000	SUPPL-5	Supplement		Label is not available on this site.
03/15/2001	SUPPL-4	Supplement		Label is not available on this site.
04/18/2000	SUPPL-3	Supplement		Label is not available on this site.
03/26/1999	SUPPL-2	Supplement	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20582-S002_FOLLISTIM_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020582s002_follistim_toc.cfm
11/18/1998	SUPPL-1	Supplement	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20582_FOLLISTIM%2075IU%20AND%20150IU%20VIALS_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020582s001_follistim_toc.cfm

Labels for BLA 020582

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2002	SUPPL-6	Tentative Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf

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