Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020304
Company: BAYER HLTHCARE
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
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 Type 1 - New Molecular Entity PRIORITY; 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 Labeling 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 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/11/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/2000 SUPPL-9 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf
09/21/1999 SUPPL-8 Labeling

Label is not available on this site.

03/05/1999 SUPPL-7 Labeling

Label is not available on this site.

09/30/1997 SUPPL-6 Labeling

Label is not available on this site.

08/08/1997 SUPPL-5 Labeling

Label is not available on this site.

08/28/1998 SUPPL-4 Efficacy-New Indication 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.cfm
01/19/1995 SUPPL-3 Labeling

Label is not available on this site.

10/12/1994 SUPPL-2 Efficacy-New Dosing Regimen

Label is not available on this site.

02/07/1994 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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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