Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020610
Company: VALEANT PHARMS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLAZAL BALSALAZIDE DISODIUM 750MG CAPSULE;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
07/18/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20610lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20610ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-610_Colazal.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2019 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020610s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020610Orig1s021ltredt.pdf
01/05/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/05/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/09/2008 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020610s018ltr.pdf
11/02/2007 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020610s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020610s017ltr.pdf
12/20/2006 SUPPL-16 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s016ltr.pdf
09/21/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s014ltr.pdf
03/10/2006 SUPPL-13 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020610s013ltr.pdf
02/07/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/18/2002 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20610s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/21/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020610s021lbl.pdf
11/02/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020610s017lbl.pdf
12/20/2006 SUPPL-16 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s016lbl.pdf
09/21/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020610s014lbl.pdf
07/18/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20610lbl.pdf

COLAZAL

CAPSULE;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG CAPSULE;ORAL Prescription No AB 077883 APOTEX INC
BALSALAZIDE DISODIUM BALSALAZIDE DISODIUM 750MG CAPSULE;ORAL Prescription No AB 077806 HIKMA
COLAZAL BALSALAZIDE DISODIUM 750MG CAPSULE;ORAL Prescription Yes AB 020610 VALEANT PHARMS INTL

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