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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020304
Company: BAYER HLTHCARE

Other Important Information from FDA

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

Products on BLA 020304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRASYLOL	APROTININ	10,000KIU/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 020304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1993	ORIG-1	Approval		N/A; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2006	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020304s022ltr.pdf
09/18/2001	SUPPL-11	Supplement		Label is not available on this site.
04/11/2001	SUPPL-10	Supplement		Label is not available on this site.
07/24/2000	SUPPL-9	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf
09/21/1999	SUPPL-8	Supplement		Label is not available on this site.
03/05/1999	SUPPL-7	Supplement		Label is not available on this site.
09/30/1997	SUPPL-6	Supplement		Label is not available on this site.
08/08/1997	SUPPL-5	Supplement		Label is not available on this site.
08/28/1998	SUPPL-4	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020304s004.html
01/19/1995	SUPPL-3	Supplement		Label is not available on this site.
10/12/1994	SUPPL-2	Supplement		Label is not available on this site.
02/07/1994	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 020304

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2006	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s022lbl.pdf
07/24/2000	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf
08/28/1998	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20304s04.pdf

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