Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022205
Company: VALEANT PHARMS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GIAZO BALSALAZIDE DISODIUM 1.1GM 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
02/03/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022205s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022205s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022205_giazo_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022205Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/05/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/16/2013 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022205Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022205Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/16/2013 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022205Orig1s001lbl.pdf
02/03/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022205s000lbl.pdf

GIAZO

TABLET;ORAL; 1.1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 1.1GM TABLET;ORAL Prescription No AB 206336 PAR PHARM INC
GIAZO BALSALAZIDE DISODIUM 1.1GM TABLET;ORAL Prescription Yes AB 022205 VALEANT PHARMS INTL

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