Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021513
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENABLEX DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
ENABLEX DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED 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
12/22/2004 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021513lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021513ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-513_Enablex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/13/2016 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/18/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/20/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/09/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/03/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/15/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513Orig1s010ltr.pdf
12/05/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/13/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513s008ltr.pdf
04/18/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021513s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021513s007ltr.pdf
10/19/2010 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021513s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021513s006ltr.pdf
12/12/2008 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s005ltrCorrectedCopy.pdf
04/18/2008 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s004ltr.pdf
10/20/2005 SUPPL-2 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021513s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021513s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/15/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s010lbl.pdf
01/13/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s008lbl.pdf
04/18/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021513s007lbl.pdf
10/19/2010 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021513s006lbl.pdf
12/12/2008 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s005lbl.pdf
04/18/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s004lbl.pdf
10/20/2005 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021513s002lbl.pdf
12/22/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021513lbl.pdf

ENABLEX

TABLET, EXTENDED RELEASE;ORAL; EQ 7.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DARIFENACIN DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207302 MACLEODS PHARMS LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091190 ANCHEN PHARMS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206743 AUROBINDO PHARMA LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207664 CIPLA LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205550 JUBILANT GENERICS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205209 TORRENT PHARMS LTD
ENABLEX DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021513 APIL

TABLET, EXTENDED RELEASE;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DARIFENACIN DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207302 MACLEODS PHARMS LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 091190 ANCHEN PHARMS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206743 AUROBINDO PHARMA LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207664 CIPLA LTD
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205550 JUBILANT GENERICS
DARIFENACIN HYDROBROMIDE DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205209 TORRENT PHARMS LTD
ENABLEX DARIFENACIN HYDROBROMIDE EQ 15MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021513 APIL

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