Dapagliflozin | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Dapagliflozin
FDA Orange Book

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Dapagliflozin

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

98 API Suppliers, 34 USDMF, 1 CEP/COS, 4 JDMF, 13 EU WC, 18 KDMF, 12 NDC API, 71 Listed Suppliers, $ API Reference Price

98 API Suppliers
34 USDMF
1 CEP/COS
4 JDMF
13 EU WC
18 KDMF
12 NDC API
71 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

241 Drugs in Development

241 Drugs in Development

INTERMEDIATES

82 Intermediate Suppliers

82 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

223 FDF Dossiers, 36 FDA Orange Book, 57 Europe, 26 Canada, 6 Australia, 18 South Africa, 80 Listed Dossiers

223 FDF Dossiers
36 FDA Orange Book
57 Europe
26 Canada
6 Australia
18 South Africa
80 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 5MG

TABLET;ORAL - 10MG
TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 3 DKSH, 3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 Clariant, 5 Corel Pharma Chem, 4 DFE Pharma, 7 Gangwal Chemicals, 2 Ideal Cures, 1 Ingredion Pharma Solutions, 8 Kerry, 2 Keval Exports, 8 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

1 SPI Pharma
3 DKSH
3 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Aeon Procare
5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 BASF
1 Clariant
5 Corel Pharma Chem
4 DFE Pharma
7 Gangwal Chemicals
2 Ideal Cures
1 Ingredion Pharma Solutions
8 Kerry
2 Keval Exports
8 Microlex e.U
2 Nitika Pharmaceutical Specialities
1 Novo Excipients
1 Pharmatrans-Sanaq
2 Pluviaendo
3 Prachin Chemical
10 Roquette
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
10 Sigachi Industries
3 Silverline Chemicals
3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

22 Fillers, Diluents & Binders, 20 Coating Systems & Additives, 15 Direct Compression, 14 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 10 Thickeners and Stabilizers, 10 Granulation, 8 Controlled & Modified Release, 7 Co-Processed Excipients, 5 Film Formers & Plasticizers, 3 Rheology Modifiers, 3 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 3 Taste Masking, 3 Topical, 2 Coloring Agents, 2 Parenteral, 2 API Stability Enhancers, 1 Surfactant & Foaming Agents

22 Fillers, Diluents & Binders
20 Coating Systems & Additives
15 Direct Compression
14 Disintegrants & Superdisintegrants
12 Lubricants & Glidants
10 Thickeners and Stabilizers
10 Granulation
8 Controlled & Modified Release
7 Co-Processed Excipients
5 Film Formers & Plasticizers
3 Rheology Modifiers
3 Emulsifying Agents
3 Chewable & Orodispersible Aids
3 Taste Masking
3 Topical
2 Coloring Agents
2 Parenteral
2 API Stability Enhancers
1 Surfactant & Foaming Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 212 News #PharmaBuzz

2 Data Compilation #PharmaFlow
212 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 57 Regulatory FDF Prices, 20 Annual Reports

1 US Medicaid Prescriptions
57 Regulatory FDF Prices
20 Annual Reports

MARKET PLACE

41 APIs, 12 FDF Dossiers

41 APIs
12 FDF Dossiers

PATENTS & EXCLUSIVITIES

195 US Patents, 18 US Exclusivities

195 US Patents
18 US Exclusivities

REF. STANDARDS & IMPURITIES

46 Others

46 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 3,122 Xls

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36 All

01 2AIZANT

02 2APOTEX INC

03 13ASTRAZENECA AB

04 2GLENMARK GENERICS

05 2HETERO LABS UNIT III

06 2JIANGSU HANSOH PHARM

07 2LUPIN LTD

08 4MACLEODS PHARMACEUTICALS LTD

09 2MSN LABORATORIES PRIVATE LTD

10 1MSN LABS PVT LTD

11 2TEVA PHARMS USA INC

12 2ZYDUS PHARMS

filter Dosage Reset all filters

36 All

01 4TABLET, EXTENDED RELEASE

02 9TABLET, EXTENDED RELEASE;ORAL

03 5TABLET; ORAL

04 18TABLET;ORAL

filter Regulatory Info Reset all filters

36 All

01 6DISCN

02 7RX

03 23Blank

filter Brand Name Reset all filters

36 All

01 16DAPAGLIFLOZIN

02 4DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

03 1DAPAGLIFLOZIN AND SAXAGLIPTIN

04 2DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE

05 2FARXIGA

06 2QTERN

07 4QTERNMET XR

08 5XIGDUO XR

filter RLD Reset all filters

36 All

01 13Yes

02 23Blank

Polpharma Dapagliflozin

List of Suppliers

Product Main Page

01

ASTRAZENECA AB

iPHEX India

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ASTRAZENECA AB

iPHEX India

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RLD : Yes

TE Code :

DAPAGLIFLOZIN

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 :

Portfolio PDF

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02

ASTRAZENECA AB

iPHEX India

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ASTRAZENECA AB

iPHEX India

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RLD : Yes

TE Code :

DAPAGLIFLOZIN

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 :

Portfolio PDF

Product Web Link

Digital Content

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03

ASTRAZENECA AB

iPHEX India

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ASTRAZENECA AB

iPHEX India

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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 :

Portfolio PDF

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04

ASTRAZENECA AB

iPHEX India

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ASTRAZENECA AB

iPHEX India

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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 :

Portfolio PDF

Product Web Link

Digital Content

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05

ASTRAZENECA AB

iPHEX India

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ASTRAZENECA AB

iPHEX India

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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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ASTRAZENECA AB

iPHEX India

Not Confirmed

ASTRAZENECA AB

iPHEX India

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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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

ASTRAZENECA AB

iPHEX India

Not Confirmed

ASTRAZENECA AB

iPHEX India

Not Confirmed

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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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

ASTRAZENECA AB

iPHEX India

Not Confirmed

ASTRAZENECA AB

iPHEX India

Not Confirmed

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Digital Content

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 :

Portfolio PDF

Product Web Link

Digital Content

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09

ASTRAZENECA AB

iPHEX India

Not Confirmed

ASTRAZENECA AB

iPHEX India

Not Confirmed

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Digital Content

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 :

Portfolio PDF

Product Web Link

Digital Content

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10

ASTRAZENECA AB

iPHEX India

Not Confirmed

ASTRAZENECA AB

iPHEX India

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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 :

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