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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020610
Company: VALEANT PHARMS INTL

Products on NDA 020610

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLAZAL	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020610

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
10/24/2023	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020610s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020610Orig1s026ltr.pdf
11/16/2022	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020610s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020610Orig1s025ltr.pdf
11/01/2021	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020610s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020610Orig1s024ltr.pdf
10/01/2020	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020610s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020610Orig1s023ltr.pdf
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

Labels for NDA 020610

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020610s026lbl.pdf
11/16/2022	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020610s025lbl.pdf
11/01/2021	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020610s024lbl.pdf
10/01/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020610s023lbl.pdf
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

Therapeutic Equivalents for NDA 020610

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
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	217592	ZYDUS LIFESCIENCES
COLAZAL	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	Yes	AB	020610	VALEANT PHARMS INTL

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