Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022430
Company: FERRING PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYSTEDA TRANEXAMIC ACID 650MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2009 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022430s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430_lysteda_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/23/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/23/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/03/2013 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s004ltr.pdf
08/21/2013 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s003ltr.pdf
04/06/2011 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022430s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/022430Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/03/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf
08/21/2013 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf
04/06/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf
11/13/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf

LYSTEDA

TABLET;ORAL; 650MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LYSTEDA TRANEXAMIC ACID 650MG TABLET;ORAL Prescription Yes AB 022430 FERRING PHARMS INC
TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET;ORAL Prescription No AB 202093 ACTAVIS LABS FL INC
TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET;ORAL Prescription No AB 202286 APOTEX INC
TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET;ORAL Prescription No AB 205133 MYLAN PHARMS INC

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