Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 021271
Company: BAUSCH

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

Products on BLA 021271

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IPRIVASK	DESIRUDIN RECOMBINANT	15MG/VIAL	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021271

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2003	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021271lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21271ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-271_Iprivask.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2015	SUPPL-7	Supplement		Label is not available on this site.
11/07/2014	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021271Orig1s006ltr.pdf
07/01/2014	SUPPL-5	Supplement		Label is not available on this site.
01/21/2010	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 021271

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021271s006lbl.pdf
04/04/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021271lbl.pdf