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01 3Dr. Reddy's Laboratories

02 2Amneal Pharmaceuticals

03 2Apotex Inc

04 18AstraZeneca

05 2Aurobindo Pharma Limited

06 2Glenmark Pharmaceuticals

07 2Sandoz B2B

08 5Sun Pharmaceutical Industries Limited

09 5Viatris

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG;EQ 5MG BASE

Packaging :

Approval Date : 2023-08-09

Application Number : 207678

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 2.5MG BASE

Packaging :

Approval Date : 2023-08-09

Application Number : 207678

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 5MG BASE

Packaging :

Approval Date : 2023-08-09

Application Number : 207678

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

04

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205941

Regulatory Info : DISCN

Registration Country : USA

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05

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205941

Regulatory Info : DISCN

Registration Country : USA

blank

06

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : ONGLYZA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2009-07-31

Application Number : 22350

Regulatory Info : DISCN

Registration Country : USA

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07

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : ONGLYZA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2009-07-31

Application Number : 22350

Regulatory Info : DISCN

Registration Country : USA

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08

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : KOMBIGLYZE XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2010-11-05

Application Number : 200678

Regulatory Info : DISCN

Registration Country : USA

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09

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : KOMBIGLYZE XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2010-11-05

Application Number : 200678

Regulatory Info : DISCN

Registration Country : USA

blank

10

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : KOMBIGLYZE XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2010-11-05

Application Number : 200678

Regulatory Info : DISCN

Registration Country : USA

blank

11

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG;EQ 5MG BASE

Packaging :

Approval Date : 2017-02-27

Application Number : 209091

Regulatory Info : RX

Registration Country : USA

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12

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG;EQ 5MG BASE

Packaging :

Approval Date : 2019-05-02

Application Number : 209091

Regulatory Info : RX

Registration Country : USA

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13

Immuno
Not Confirmed
arrow
arrow
Immuno
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

Packaging :

Approval Date : 2019-05-02

Application Number : 210874

Regulatory Info : DISCN

Registration Country : USA

blank

14

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERNMET XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1GM;EQ 2.5MG BASE

Packaging :

Approval Date : 2019-05-02

Application Number : 210874

Regulatory Info : DISCN

Registration Country : USA

blank

15

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERNMET XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1GM;EQ 5MG BASE

Packaging :

Approval Date : 2019-05-02

Application Number : 210874

Regulatory Info : DISCN

Registration Country : USA

blank

16

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : QTERNMET XR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG;1GM;EQ 5MG BASE

Packaging :

Approval Date : 2019-05-02

Application Number : 210874

Regulatory Info : DISCN

Registration Country : USA

blank

17

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205972

Regulatory Info : RX

Registration Country : USA

blank

18

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205972

Regulatory Info : RX

Registration Country : USA

blank

19

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205994

Regulatory Info : RX

Registration Country : USA

blank

20

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205994

Regulatory Info : RX

Registration Country : USA

blank

21

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 206078

Regulatory Info : RX

Registration Country : USA

blank

22

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 206078

Regulatory Info : RX

Registration Country : USA

blank

23

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG;EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 206081

Regulatory Info : RX

Registration Country : USA

blank

24

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 2.5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 206081

Regulatory Info : RX

Registration Country : USA

blank

25

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 206081

Regulatory Info : RX

Registration Country : USA

blank

26

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2.5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205980

Regulatory Info : RX

Registration Country : USA

blank

27

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205980

Regulatory Info : RX

Registration Country : USA

blank

28

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 500MG;EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205981

Regulatory Info : RX

Registration Country : USA

blank

29

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 2.5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205981

Regulatory Info : RX

Registration Country : USA

blank

30

Immuno
Not Confirmed
arrow
arrow
Immuno
Not Confirmed

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 1GM;EQ 5MG BASE

Packaging :

Approval Date : 2023-07-31

Application Number : 205981

Regulatory Info : RX

Registration Country : USA

blank