Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202093
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANEXAMIC ACID TRANEXAMIC ACID 650MG TABLET;ORAL Prescription AB 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
12/27/2012 ORIG-1 Approval Not Applicable Letter (PDF)
Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202093Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202093Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2015 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

TRANEXAMIC ACID

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

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