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01 2AIZANT

02 2AJANTA PHARMA LTD

03 2ALEMBIC

04 6ALKEM LABS LTD

05 2APOTEX INC

06 13ASTRAZENECA AB

07 7AUROBINDO PHARMA

08 2BIOCON PHARMA

09 1CENTAUR PHARMACEUTICALS PRIVATE LIMITED

10 3CIPLA

11 3CIPLA LTD

12 2GLENMARK GENERICS

13 2HETERO LABS UNIT III

14 2INVENTIA

15 4INVENTIA HEALTHCARE LIMITED

16 2JIANGSU HANSOH PHARM

17 6LUPIN

18 2LUPIN LTD

19 6MACLEODS PHARMS LTD

20 6MICRO LABS

21 7MSN

22 2SANDOZ

23 2SCIEGEN PHARMACEUTICALS INC

24 4SINOTHERAPEUTICS INC

25 3SUN PHARM

26 2TEVA PHARMS USA

27 5TEVA PHARMS USA INC

28 1TORRENT

29 2ZYDUS PHARMS

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PharmaCompass

01

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN

Brand Name : FARXIGA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2014-01-08

Application Number : 202293

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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02

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN

Brand Name : FARXIGA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2014-01-08

Application Number : 202293

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : XIGDUO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;500MG

Approval Date : 2014-10-29

Application Number : 205649

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : XIGDUO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1GM

Approval Date : 2014-10-29

Application Number : 205649

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : XIGDUO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;500MG

Approval Date : 2014-10-29

Application Number : 205649

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : XIGDUO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;1GM

Approval Date : 2014-10-29

Application Number : 205649

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : XIGDUO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG;1GM

Approval Date : 2017-07-28

Application Number : 205649

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;EQ 5MG BASE

Approval Date : 2017-02-27

Application Number : 209091

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;EQ 5MG BASE

Approval Date : 2019-05-02

Application Number : 209091

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERNMET XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG;1GM;EQ 2.5MG BASE

Approval Date : 2019-05-02

Application Number : 210874

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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