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

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01 3AMNEAL PHARMS

02 2LUPIN LTD

03 1MSN LABS PVT LTD

04 1PAR PHARM

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PharmaCompass

01

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Not Confirmed
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SAXAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;500MG

Approval Date :

Application Number : 205942

RX/OTC/DISCN :

RLD :

TE Code :

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02

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

SAXAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG;1000MG

Approval Date :

Application Number : 205942

RX/OTC/DISCN :

RLD :

TE Code :

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03

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

SAXAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1000MG

Approval Date :

Application Number : 205942

RX/OTC/DISCN :

RLD :

TE Code :

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04

Luxepack
Not Confirmed
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Luxepack
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DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE

Brand Name : DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE

Dosage Form : TABLET; ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 211532

RX/OTC/DISCN :

RLD :

TE Code :

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05

Luxepack
Not Confirmed
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Luxepack
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DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE

Brand Name : DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE

Dosage Form : TABLET; ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 211532

RX/OTC/DISCN :

RLD :

TE Code :

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06

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

DAPAGLIFLOZIN; SAXAGLIPTIN

Brand Name : DAPAGLIFLOZIN AND SAXAGLIPTIN

Dosage Form : TABLET; ORAL

Dosage Strength : 10MG/5MG

Approval Date :

Application Number : 211533

RX/OTC/DISCN :

RLD :

TE Code :

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07

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Not Confirmed
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SAXAGLIPTIN

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date :

Application Number : 205959

RX/OTC/DISCN :

RLD :

TE Code :

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