Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022205
Company: VALEANT PHARMS INTL
Company: VALEANT PHARMS INTL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GIAZO | BALSALAZIDE DISODIUM | 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
11/01/2021 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022205s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022205Orig1s005ltr.pdf | |
10/01/2020 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022205Orig1s004ltr.pdf | |
01/07/2020 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022205Orig1s003ltr.pdf | |
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 |
---|---|---|---|---|---|
11/01/2021 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022205s005lbl.pdf | |
10/01/2020 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s004lbl.pdf | |
01/07/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022205s003lbl.pdf | |
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 |