Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021427
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
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-Medication Guide, Labeling-Package Insert 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
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-Medication Guide 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
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 PHARMS LTD
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 090780 ANCHEN PHARMS
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202045 APOTEX INC
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 PHARM
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090723 DR REDDYS LABS LTD
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 HLTHCARE
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 090745 SUN PHARMA GLOBAL
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090783 TEVA PHARMS USA
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090774 TORRENT PHARMS LTD
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 USA INC

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 PHARMS LTD
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 090780 ANCHEN PHARMS
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202045 APOTEX INC
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 PHARM
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090723 DR REDDYS LABS LTD
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 HLTHCARE
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 090745 SUN PHARMA GLOBAL
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090783 TEVA PHARMS USA
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090774 TORRENT PHARMS LTD
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 USA INC

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 PHARMS LTD
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 090780 ANCHEN PHARMS
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 202045 APOTEX INC
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 PHARM
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090723 DR REDDYS LABS LTD
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 HLTHCARE
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 090745 SUN PHARMA GLOBAL
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090783 TEVA PHARMS USA
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription No AB 090774 TORRENT PHARMS LTD
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 USA INC

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