اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
COLAZAL از شرکت VALEANT PHARMS INTL
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20610lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/01/2020 | SUPPL-23 | Labeling-Package Insert |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020610s018ltr.pdf |
|
| 11/02/2007 | SUPPL-17 | Labeling |
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 |
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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 10/01/2020 | 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 |
| COLAZAL | BALSALAZIDE DISODIUM | 750MG | CAPSULE;ORAL | Prescription | Yes | AB | 020610 | VALEANT PHARMS INTL |
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