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

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01 3AIZANT

02 4ALKEM LABS LTD

03 4ANNORA PHARMA

04 16BOEHRINGER INGELHEIM

05 2KINAPSE LIMITED

06 2LAURUS GENERICS INC

07 4LUPIN LTD

08 6MSN LABS PVT LTD

09 1PRINSTON PHARMA INC

10 2SUN PHARM INDS LTD

11 6ZYDUS PHARMS

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PharmaCompass

01

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN

Brand Name : JARDIANCE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2014-08-01

Application Number : 204629

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN

Brand Name : JARDIANCE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2014-08-01

Application Number : 204629

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

Discovery on Target
Not Confirmed
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Discovery on Target
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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04

Discovery on Target
Not Confirmed
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Discovery on Target
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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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : SYNJARDY

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;500MG

Approval Date : 2015-08-26

Application Number : 206111

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : SYNJARDY

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;1GM

Approval Date : 2015-08-26

Application Number : 206111

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : SYNJARDY

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG;500MG

Approval Date : 2015-08-26

Application Number : 206111

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : SYNJARDY

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG;1GM

Approval Date : 2015-08-26

Application Number : 206111

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : SYNJARDY XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1GM

Approval Date : 2016-12-09

Application Number : 208658

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Brand Name : SYNJARDY XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;1GM

Approval Date : 2016-12-09

Application Number : 208658

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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