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01 2AIZANT
02 2APOTEX INC
03 13ASTRAZENECA AB
04 1AUROBINDO PHARMA LIMITED
05 2GLENMARK GENERICS
06 2HETERO LABS UNIT III
07 2JIANGSU HANSOH PHARM
08 2LUPIN LTD
09 4MACLEODS PHARMACEUTICALS LTD
10 2MSN LABORATORIES PRIVATE LTD
11 1MSN LABS PVT LTD
12 4SINOTHERAPEUTICS INC
13 2TEVA PHARMS USA INC
14 2ZYDUS PHARMS
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01 5TABLET
02 4TABLET, EXTENDED RELEASE
03 9TABLET, EXTENDED RELEASE;ORAL
04 5TABLET; ORAL
05 18TABLET;ORAL
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01 6DISCN
02 7RX
03 28Blank
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01 17DAPAGLIFLOZIN
02 4DAPAGLIFLOZIN AND METFORMIN
03 4DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
04 1DAPAGLIFLOZIN AND SAXAGLIPTIN
05 2DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE
06 2FARXIGA
07 2QTERN
08 4QTERNMET XR
09 5XIGDUO XR
01 13Yes
02 28Blank
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :