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Abbreviated New Drug Application (ANDA): 090728
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/08/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090728Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2015 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

DULOXETINE HYDROCHLORIDE

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
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 090723 MARKSANS PHARMA
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 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
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 090723 MARKSANS PHARMA
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 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
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 090723 MARKSANS PHARMA
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
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