Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021324
Company: PERRIGO PHARMA INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENTOCORT EC BUDESONIDE 3MG 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
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
01/18/2019 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021324s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021324Orig1s018ltr.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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021324s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021324s008ltr.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
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;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;ORAL Prescription No AB 206724 ALVOGEN
BUDESONIDE BUDESONIDE 3MG CAPSULE;ORAL Prescription No AB 206200 AMNEAL PHARMS
BUDESONIDE BUDESONIDE 3MG CAPSULE;ORAL Prescription No AB 207367 APPCO PHARMA LLC
BUDESONIDE BUDESONIDE 3MG CAPSULE;ORAL Prescription No AB 090379 BARR LABS DIV TEVA
BUDESONIDE BUDESONIDE 3MG CAPSULE;ORAL Prescription No AB 206623 MAYNE PHARMA
BUDESONIDE BUDESONIDE 3MG CAPSULE;ORAL Prescription No AB 090410 MYLAN
BUDESONIDE BUDESONIDE 3MG CAPSULE;ORAL Prescription No AB 209041 SCIECURE PHARMA INC
BUDESONIDE BUDESONIDE 3MG CAPSULE;ORAL Prescription No AB 206134 ZYDUS PHARMS
ENTOCORT EC BUDESONIDE 3MG CAPSULE;ORAL Prescription Yes AB 021324 PERRIGO PHARMA INTL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English