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
CREON از شرکت ABBVIE
Biologic License Application (BLA): 020725
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 30,000USP UNITS;6,000USP UNITS;19,000USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription |
None |
No | No |
| CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 60,000USP UNITS;12,000USP UNITS;38,000USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription |
None |
No | No |
| CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 120,000USP UNITS;24,000USP UNITS;76,000USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription |
None |
No | No |
| CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 15,000USP UNITS;3,000USP UNITS;9,500USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription |
None |
No | No |
| CREON | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 180,000USP UNITS;36,000USP UNITS;114,000USP UNITS | CAPSULE, DELAYED RELEASE;ORAL | Prescription |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/2009 | ORIG-1 | Approval |
N/A |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/2020 | SUPPL-26 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020725Orig1s026ltr.pdf |
||
| 05/09/2019 | SUPPL-25 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020725Orig1s025ltr.pdf |
|
| 06/16/2016 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 04/10/2015 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 11/19/2014 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
| 11/21/2014 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 02/28/2013 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 03/14/2013 | SUPPL-16 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf |
||
| 11/20/2012 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 05/09/2011 | SUPPL-14 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s014ltr.pdf |
||
| 06/10/2011 | SUPPL-11 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020725s011ltr.pdf |
||
| 03/17/2014 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 07/12/2011 | SUPPL-8 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s008lbl.pdf |
||
| 08/12/2010 | SUPPL-7 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s007ltr.pdf |
||
| 07/29/2010 | SUPPL-6 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s006ltr.pdf |
||
| 04/30/2010 | SUPPL-3 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020725s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/20/2020 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020725s026lbl.pdf | |
| 03/14/2013 | SUPPL-16 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020725s016lbl.pdf |
| 07/12/2011 | SUPPL-8 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s008lbl.pdf | |
| 06/10/2011 | SUPPL-11 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf |
| 05/09/2011 | SUPPL-14 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf | |
| 08/12/2010 | SUPPL-7 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf | |
| 07/29/2010 | SUPPL-6 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf | |
| 04/30/2010 | SUPPL-3 |
Efficacy-New Patient Population |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf | |
| 04/30/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020725s000lbl.pdf |
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