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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021289
Company: FERRING

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

Products on BLA 021289

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRAVELLE	UROFOLLITROPIN	75 IU/VIAL	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021289

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2002	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-289_Bravelle_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21289ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-289_Bravelle.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/27/2015	SUPPL-27	Supplement		Label is not available on this site.
07/27/2015	SUPPL-26	Supplement		Label is not available on this site.
09/10/2015	SUPPL-25	Supplement		Label is not available on this site.
07/18/2014	SUPPL-22	Supplement		Label is not available on this site.
07/11/2014	SUPPL-21	Supplement		Label is not available on this site.
02/19/2014	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021289Orig1s019ltr.pdf
11/14/2002	SUPPL-2	Supplement		Label is not available on this site.

Labels for BLA 021289

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2014	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021289s019lbl.pdf
05/06/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-289_Bravelle_prntlbl.pdf

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