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, 12 EU WC, 18 KDMF, 12 NDC API, 71 Listed Suppliers, $ API Reference Price

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

DEVELOPMENTS

261 Drugs in Development

261 Drugs in Development

INTERMEDIATES

82 Intermediate Suppliers

82 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

213 FDF Dossiers, 40 FDA Orange Book, 43 Europe, 26 Canada, 6 Australia, 18 South Africa, 80 Listed Dossiers

213 FDF Dossiers
40 FDA Orange Book
43 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, 213 News #PharmaBuzz

2 Data Compilation #PharmaFlow
213 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 43 Regulatory FDF Prices, 20 Annual Reports

1 US Medicaid Prescriptions
43 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) : 3,065 Xls

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40 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 4SINOTHERAPEUTICS INC

12 2TEVA PHARMS USA INC

13 2ZYDUS PHARMS

filter Dosage Reset all filters

40 All

01 4TABLET

02 4TABLET, EXTENDED RELEASE

03 9TABLET, EXTENDED RELEASE;ORAL

04 5TABLET; ORAL

05 18TABLET;ORAL

filter Regulatory Info Reset all filters

40 All

01 6DISCN

02 7RX

03 27Blank

filter Brand Name Reset all filters

40 All

01 16DAPAGLIFLOZIN

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

filter RLD Reset all filters

40 All

01 13Yes

02 27Blank

Polpharma Dapagliflozin

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Product Main Page

01

ASTRAZENECA AB

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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 :

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ASTRAZENECA AB

OPRD

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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 :

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03

ASTRAZENECA AB

OPRD

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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 :

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ASTRAZENECA AB

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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 :

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ASTRAZENECA AB

OPRD

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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

OPRD

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ASTRAZENECA AB

OPRD

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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

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07

ASTRAZENECA AB

OPRD

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ASTRAZENECA AB

OPRD

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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

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08

ASTRAZENECA AB

OPRD

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ASTRAZENECA AB

OPRD

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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

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09

ASTRAZENECA AB

OPRD

Not Confirmed

ASTRAZENECA AB

OPRD

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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

OPRD

Not Confirmed

ASTRAZENECA AB

OPRD

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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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