Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021513
Company: APIL
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 | 207681 | ALEMBIC PHARMS LTD |
| 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 |
| 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 | 211045 | POLYGEN PHARMS |
| DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205209 | TORRENT |
| 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 | 207681 | ALEMBIC PHARMS LTD |
| 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 |
| 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 | 211045 | POLYGEN PHARMS |
| DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205209 | TORRENT |
| ENABLEX | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021513 | APIL |
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