Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021324
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ENTOCORT EC | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 10/02/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Patient Package Insert (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324PPIlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021324s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021324Orig1s027ltr.pdf | |
| 07/15/2020 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021324Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021324Orig1s023ltr.pdf | |
| 01/18/2019 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021324s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021324Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/021324Orig1s018.pdf | |
| 10/17/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021324s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021324Orig1s016ltr.pdf | |
| 04/29/2016 | SUPPL-13 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf | |
| 04/29/2016 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf | |
| 12/20/2011 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021324s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021324s009ltr.pdf | |
| 06/22/2009 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021324s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021324s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021324Orig1s008.pdf | |
| 04/29/2005 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021324s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021324s005ltr.pdf | |
| 03/13/2003 | SUPPL-4 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21324scm004ltr.pdf |
| 10/03/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs003ltr.pdf |
| 08/14/2002 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/09/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021324s027lbl.pdf | |
| 07/15/2020 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021324Orig1s023lbl.pdf | |
| 07/15/2020 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021324Orig1s023lbl.pdf | |
| 07/15/2020 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021324Orig1s023lbl.pdf | |
| 01/18/2019 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021324s018lbl.pdf | |
| 10/17/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021324s016lbl.pdf | |
| 04/29/2016 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf | |
| 04/29/2016 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf | |
| 12/20/2011 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021324s009lbl.pdf | |
| 06/22/2009 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021324s008lbl.pdf | |
| 04/29/2005 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021324s005lbl.pdf | |
| 10/02/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324lbl.pdf |
ENTOCORT EC
CAPSULE, DELAYED RELEASE;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 206200 | AMNEAL PHARMS |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 090410 | AUROBINDO PHARMA USA |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 206623 | DR REDDYS LABS SA |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 207367 | RISING |
| BUDESONIDE | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | No | AB | 206134 | ZYDUS PHARMS |
| ENTOCORT EC | BUDESONIDE | 3MG | CAPSULE, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 021324 | PADAGIS US |