Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021427
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | Yes | No |
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 08/03/2004 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21427lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21427ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021427_s000_Cymbalta.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-57 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021427s055s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021427Orig1s055,s057ltr.pdf | |
| 09/20/2021 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021427s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021427Orig1s056ltr.pdf | |
| 08/18/2023 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021427s055s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021427Orig1s055,s057ltr.pdf | |
| 10/01/2020 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021427Orig1s053ltr.pdf | |
| 04/20/2020 | SUPPL-52 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021427Orig1s052ltr.pdf | |
| 10/04/2019 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021427s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021427Orig1s051ltr.pdf | |
| 12/19/2017 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021427Orig1s050ltr.pdf | |
| 01/04/2017 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021427Orig1s049ltr.pdf | |
| 09/02/2016 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021427s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021427Orig1s048ltr.pdf | |
| 07/12/2016 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/2015 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021427s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021427Orig1s046ltr.pdf | |
| 07/17/2014 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s045ltr.pdf | |
| 10/16/2014 | SUPPL-44 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s043,s044ltr.pdf | |
| 10/16/2014 | SUPPL-43 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s043,s044ltr.pdf | |
| 11/25/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s037,s042ltr.pdf | |
| 10/18/2012 | SUPPL-41 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s040,s041ltr.pdf | |
| 10/18/2012 | SUPPL-40 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s040,s041ltr.pdf | |
| 09/02/2011 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021427Orig1s039.pdf | |
| 08/24/2012 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s032,s038ltr.pdf | |
| 11/25/2014 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021427Orig1s037,s042ltr.pdf | |
| 04/12/2011 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s036ltr.pdf | |
| 08/24/2012 | SUPPL-32 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021427Orig1s032,s038ltr.pdf | |
| 03/04/2011 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021427s031ltr.pdf | |
| 11/19/2009 | SUPPL-30 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s030ltr.pdf | |
| 01/30/2009 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s029ltr.pdf | |
| 03/18/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf | |
| 03/18/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf | |
| 03/18/2009 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021427s021,s027,s028ltr.pdf | |
| 08/02/2007 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf | |
| 11/28/2007 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s015, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021427Orig1s015_s017.pdf | |
| 11/28/2007 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s015, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021427Orig1s015_s017.pdf | |
| 02/23/2007 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf | |
| 09/20/2006 | SUPPL-12 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021427s012lbl.pdf | |
| 02/23/2007 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf | |
| 02/23/2007 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s009, 021427s011, 021427s013ltr.pdf | |
| 06/06/2006 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021427s007LTR.pdf |
| 02/18/2005 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21427s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-57 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021427s055s057lbl.pdf | |
| 08/18/2023 | SUPPL-57 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021427s055s057lbl.pdf | |
| 08/18/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021427s055s057lbl.pdf | |
| 09/20/2021 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021427s056lbl.pdf | |
| 10/01/2020 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s053lbl.pdf | |
| 04/20/2020 | SUPPL-52 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s052lbl.pdf | |
| 10/04/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021427s051lbl.pdf | |
| 12/19/2017 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s050lbl.pdf | |
| 01/04/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf | |
| 09/02/2016 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021427s048lbl.pdf | |
| 06/18/2015 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021427s046lbl.pdf | |
| 11/25/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf | |
| 11/25/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf | |
| 10/16/2014 | SUPPL-44 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf | |
| 10/16/2014 | SUPPL-43 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf | |
| 07/17/2014 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427Orig1s045lbl.pdf | |
| 10/18/2012 | SUPPL-41 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf | |
| 10/18/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf | |
| 10/18/2012 | SUPPL-40 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf | |
| 08/24/2012 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf | |
| 08/24/2012 | SUPPL-32 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf | |
| 09/02/2011 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s039lbl.pdf | |
| 04/12/2011 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s036lbl.pdf | |
| 03/04/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s031lbl.pdf | |
| 11/19/2009 | SUPPL-30 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s030lbl.pdf | |
| 03/18/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf | |
| 03/18/2009 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf | |
| 03/18/2009 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf | |
| 01/30/2009 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s029lbl.pdf | |
| 11/28/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf | |
| 11/28/2007 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf | |
| 08/02/2007 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s018lbl.pdf | |
| 02/23/2007 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf | |
| 02/23/2007 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf | |
| 02/23/2007 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf | |
| 09/20/2006 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021427s012lbl.pdf | |
| 08/03/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21427lbl.pdf |
CYMBALTA
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021427 | LILLY |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090776 | ACTAVIS ELIZABETH |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208706 | AJANTA PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202949 | ALEMBIC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203197 | ALKEM LABS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090778 | AUROBINDO PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203088 | BRECKENRIDGE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211310 | CSPC OUYI |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204343 | HETERO LABS LTD III |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202336 | INVENTIA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090694 | LUPIN LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204815 | MACLEODS PHARMS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206653 | PRINSTON INC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210599 | QINGDAO BAHEAL PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090745 | SUN PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212328 | SUNSHINE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090774 | TORRENT |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090739 | ZYDUS HLTHCARE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090728 | ZYDUS PHARMS |
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 30MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021427 | LILLY |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090776 | ACTAVIS ELIZABETH |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208706 | AJANTA PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202949 | ALEMBIC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203197 | ALKEM LABS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090778 | AUROBINDO PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203088 | BRECKENRIDGE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211310 | CSPC OUYI |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204343 | HETERO LABS LTD III |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202336 | INVENTIA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090694 | LUPIN LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204815 | MACLEODS PHARMS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206653 | PRINSTON INC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210599 | QINGDAO BAHEAL PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090745 | SUN PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212328 | SUNSHINE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090774 | TORRENT |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090739 | ZYDUS HLTHCARE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090728 | ZYDUS PHARMS |
CAPSULE, DELAYED REL PELLETS;ORAL; EQ 60MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYMBALTA | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 021427 | LILLY |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090776 | ACTAVIS ELIZABETH |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 208706 | AJANTA PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202949 | ALEMBIC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203197 | ALKEM LABS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090778 | AUROBINDO PHARMA LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 203088 | BRECKENRIDGE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 211310 | CSPC OUYI |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204343 | HETERO LABS LTD III |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 202336 | INVENTIA |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090694 | LUPIN LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 204815 | MACLEODS PHARMS LTD |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 206653 | PRINSTON INC |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 210599 | QINGDAO BAHEAL PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090745 | SUN PHARM |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 212328 | SUNSHINE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090774 | TORRENT |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090739 | ZYDUS HLTHCARE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 090728 | ZYDUS PHARMS |