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
CANASA از شرکت ALLERGAN
New Drug Application (NDA): 021252
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CANASA | MESALAMINE | 500MG | SUPPOSITORY;RECTAL | Discontinued |
None |
No | No |
| CANASA | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/05/2001 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21252lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/01/2020 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021252s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021252Orig1s025ltr.pdf |
||
| 07/27/2017 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021252s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021252Orig1s023ltr.pdf |
||
| 07/30/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2013 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s020ltr.pdf |
||
| 01/02/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/24/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/2016 | SUPPL-14 | Efficacy-New Patient Population |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021252s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021252Orig1s014ltr.pdf |
||
| 02/06/2013 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s013ltr.pdf |
||
| 05/23/2008 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021252s009ltr.pdf |
|
| 06/08/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021252s007LTR.pdf |
|
| 09/23/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s006ltr.pdf |
|
| 11/05/2004 | SUPPL-5 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21252s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s005ltr.pdf |
||
| 10/14/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21252slr002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/01/2020 | SUPPL-25 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021252s025lbl.pdf | |
| 10/01/2020 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021252s025lbl.pdf | |
| 07/27/2017 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021252s023lbl.pdf | |
| 09/02/2016 | SUPPL-14 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021252s014lbl.pdf | |
| 12/17/2013 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s020lbl.pdf | |
| 02/06/2013 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s013lbl.pdf | |
| 11/05/2004 | SUPPL-5 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21252s005lbl.pdf | |
| 01/05/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21252lbl.pdf |
CANASA
SUPPOSITORY;RECTAL; 1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CANASA | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | Yes | AB | 021252 | ALLERGAN |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 205654 | ACTAVIS MID ATLANTIC |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 210509 | AMNEAL |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 208362 | AMRING PHARMS |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 213377 | ANNORA PHARMA |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 204354 | MYLAN |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 207448 | PHARM SOURCING |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 202065 | SANDOZ INC |
| MESALAMINE | MESALAMINE | 1GM | SUPPOSITORY;RECTAL | Prescription | No | AB | 208953 | ZYDUS PHARMS |
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