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01 2ALKEM LABS LTD

02 2ANNORA PHARMA

03 1AUROBINDO PHARMA LTD

04 12BOEHRINGER INGELHEIM

05 4DR REDDYS LABS LTD

06 1INVAGEN PHARMS

07 2KINAPSE LIMITED

08 2MSN LABS PVT LTD

09 3MYLAN PHARMS INC

10 3PRINSTON PHARMA INC

11 3SUN PHARM INDS LTD

12 4SUNSHINE

13 4ZYDUS PHARMS

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PharmaCompass

01

American Pharma Summit
Not Confirmed
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American Pharma Summit
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LINAGLIPTIN

Brand Name : TRADJENTA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2011-05-02

Application Number : 201280

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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02

American Pharma Summit
Not Confirmed
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American Pharma Summit
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LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : JENTADUETO

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG;500MG

Approval Date : 2012-01-30

Application Number : 201281

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : JENTADUETO

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG;850MG

Approval Date : 2012-01-30

Application Number : 201281

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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04

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : JENTADUETO

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG;1GM

Approval Date : 2012-01-30

Application Number : 201281

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

EMPAGLIFLOZIN; LINAGLIPTIN

Brand Name : GLYXAMBI

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;5MG

Approval Date : 2015-01-30

Application Number : 206073

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

EMPAGLIFLOZIN; LINAGLIPTIN

Brand Name : GLYXAMBI

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;5MG

Approval Date : 2015-01-30

Application Number : 206073

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : JENTADUETO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG;1GM

Approval Date : 2016-05-27

Application Number : 208026

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : JENTADUETO XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1GM

Approval Date : 2016-05-27

Application Number : 208026

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LINAGLIPTIN

Brand Name : LINAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2021-08-31

Application Number : 208335

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 2.5MG;500MG

Approval Date : 2021-08-30

Application Number : 208336

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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