(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol
FDA Orange Book

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(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

103 API Suppliers, 36 USDMF, 2 CEP/COS, 4 JDMF, 12 EU WC, 18 KDMF, 14 NDC API, 75 Listed Suppliers

103 API Suppliers
36 USDMF
2 CEP/COS
4 JDMF
12 EU WC
18 KDMF
14 NDC API
75 Listed Suppliers

DEVELOPMENTS

193 Drugs in Development

193 Drugs in Development

INTERMEDIATES

95 Intermediate Suppliers

95 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

338 FDF Dossiers, 102 FDA Orange Book, 68 Europe, 28 Canada, 15 Australia, 27 South Africa, 98 Listed Dossiers

338 FDF Dossiers
102 FDA Orange Book
68 Europe
28 Canada
15 Australia
27 South Africa
98 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

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

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Dr. Paul Lohmann GmbH & Co. KGaA, 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, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Pharmachem, 10 Roquette, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

1 SPI Pharma
3 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Dr. Paul Lohmann GmbH & Co. KGaA
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
1 Neelkanth MineChem
2 Nitika Pharmaceutical Specialities
1 Novo Excipients
1 Pharmatrans-Sanaq
2 Pluviaendo
3 Prachin Pharmachem
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, 18 Coating Systems & Additives, 15 Direct Compression, 13 Disintegrants & Superdisintegrants, 12 Lubricants & Glidants, 11 Thickeners and Stabilizers, 10 Granulation, 8 Co-Processed Excipients, 8 Controlled & Modified Release, 5 Film Formers & Plasticizers, 3 Emulsifying Agents, 3 Chewable & Orodispersible Aids, 3 Taste Masking, 3 Topical, 3 Rheology Modifiers, 2 Parenteral, 2 API Stability Enhancers, 1 Surfactant & Foaming Agents

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

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 259 News #PharmaBuzz

3 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
259 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Regulatory FDF Prices, 20 Annual Reports

1 US Medicaid Prescriptions
3 Regulatory FDF Prices
20 Annual Reports

MARKET PLACE

45 APIs, 12 FDF Dossiers

45 APIs
12 FDF Dossiers

PATENTS & EXCLUSIVITIES

182 US Patents, 18 US Exclusivities

182 US Patents
18 US Exclusivities

REF. STANDARDS & IMPURITIES

46 Others

46 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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102 All

01 2AIZANT

02 2AJANTA PHARMA LTD

03 2ALEMBIC

04 6ALKEM LABS LTD

05 2APOTEX INC

06 13ASTRAZENECA AB

07 7AUROBINDO PHARMA

08 2BIOCON PHARMA

09 3CIPLA

10 3CIPLA LTD

11 2GLENMARK GENERICS

12 2HETERO LABS UNIT III

13 2INVENTIA

14 4INVENTIA HEALTHCARE LIMITED

15 2JIANGSU HANSOH PHARM

16 6LUPIN

17 2LUPIN LTD

18 6MACLEODS PHARMS LTD

19 6MICRO LABS

20 7MSN

21 2SANDOZ

22 2SCIEGEN PHARMACEUTICALS INC

23 4SINOTHERAPEUTICS INC

24 3SUN PHARM

25 2TEVA PHARMS USA

26 5TEVA PHARMS USA INC

27 1TORRENT

28 2ZYDUS PHARMS

filter Dosage Reset all filters

102 All

01 7TABLET

02 4TABLET, EXTENDED RELEASE

03 45TABLET, EXTENDED RELEASE;ORAL

04 2TABLET; ORAL

05 44TABLET;ORAL

filter Regulatory Info Reset all filters

102 All

01 6DISCN

02 75RX

03 21Blank

filter Brand Name Reset all filters

102 All

01 40DAPAGLIFLOZIN

02 4DAPAGLIFLOZIN AND METFORMIN

03 41DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

04 2DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE

05 2DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE

06 2FARXIGA

07 2QTERN

08 4QTERNMET XR

09 5XIGDUO XR

filter RLD Reset all filters

102 All

01 68No

02 13Yes

03 21Blank

Polpharma Dapagliflozin

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RLD : Yes

TE Code : AB

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 : AB

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RLD : Yes

TE Code : AB

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 : AB

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RLD : Yes

TE Code : AB

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 : AB

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RLD : Yes

TE Code : AB

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 : AB

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RLD : Yes

TE Code : AB

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 : AB

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ASTRAZENECA AB

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RLD : Yes

TE Code : AB

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 : AB

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ASTRAZENECA AB

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RLD : Yes

TE Code : AB

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 : AB

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ASTRAZENECA AB

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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 :

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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 :

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ASTRAZENECA AB

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ASTRAZENECA AB

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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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