Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020610
Company: VALEANT PHARMS INTL
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 |
---|---|---|---|---|---|
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 |
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 |
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 |