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Approved Drug Products containing Duloxetine HCl listed in the FDA Orange Book. Original Data : FDA Website

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01 4BRECKENRIDGE

02 3ACTAVIS ELIZABETH

03 4AJANTA PHARMA LTD

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05 3ALKEM LABS LTD

06 3APOTEX

07 3AUROBINDO PHARMA LTD

08 3CSPC OUYI

09 3ENDO OPERATIONS

10 3HETERO LABS LTD III

11 3IMPAX LABS INC

12 3INVENTIA

13 12LILLY

14 4LUPIN LTD

15 3MACLEODS PHARMS LTD

16 3MARKSANS PHARMA

17 3PRINSTON INC

18 3QINGDAO BAHEAL PHARM

19 3SANDOZ

20 7SUN PHARM

21 3SUNSHINE

22 3TEVA PHARMS USA

23 3TORRENT

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PharmaCompass

01

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Not Confirmed

DULOXETINE HYDROCHLORIDE

Brand Name : DULOXETINE HYDROCHLORIDE

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2014-06-11

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

02

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DULOXETINE HYDROCHLORIDE

Brand Name : DULOXETINE HYDROCHLORIDE

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2014-06-11

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

03

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Not Confirmed

DULOXETINE HYDROCHLORIDE

Brand Name : DULOXETINE HYDROCHLORIDE

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 60MG BASE

Approval Date : 2014-06-11

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

04

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DULOXETINE HYDROCHLORIDE

Brand Name : DULOXETINE HYDROCHLORIDE

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 40MG BASE

Approval Date : 2018-05-18

Application Number : 203088

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

05

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DULOXETINE HYDROCHLORIDE

Brand Name : CYMBALTA

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2004-08-03

Application Number : 21427

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

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Not Confirmed

DULOXETINE HYDROCHLORIDE

Brand Name : CYMBALTA

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 30MG BASE

Approval Date : 2004-08-03

Application Number : 21427

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

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Not Confirmed
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Not Confirmed

DULOXETINE HYDROCHLORIDE

Brand Name : CYMBALTA

Dosage Form : CAPSULE, DELAYED REL PELLETS;ORAL

Dosage Strength : EQ 60MG BASE

Approval Date : 2004-08-03

Application Number : 21427

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

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DULOXETINE HYDROCHLORIDE

Brand Name : CYMBALTA

Dosage Form : CAPSULE, DELAYED REL PELLETS; ORAL

Dosage Strength : EQ 20MG BASE

Approval Date :

Application Number : 21733

RX/OTC/DISCN :

RLD :

TE Code :

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09

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Not Confirmed
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Not Confirmed

DULOXETINE HYDROCHLORIDE

Brand Name : CYMBALTA

Dosage Form : CAPSULE, DELAYED REL PELLETS; ORAL

Dosage Strength : EQ 30MG BASE

Approval Date :

Application Number : 21733

RX/OTC/DISCN :

RLD :

TE Code :

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10

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Not Confirmed
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Not Confirmed

DULOXETINE HYDROCHLORIDE

Brand Name : CYMBALTA

Dosage Form : CAPSULE, DELAYED REL PELLETS; ORAL

Dosage Strength : EQ 60MG BASE

Approval Date :

Application Number : 21733

RX/OTC/DISCN :

RLD :

TE Code :

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