3-(CYCLOPROPYLMETHOXY)-N-(3,5-DICHLOROPYRIDIN-4-YL)-4-(DIFLUOROMETHOXY)BENZAMIDE | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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3-(CYCLOPROPYLMETHOXY)-N-(3,5-DICHLOROPYRIDIN-4-YL)-4-(DIFLUOROMETHOXY)BENZAMIDE
FDA Orange Book

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3-(CYCLOPROPYLMETHOXY)-N-(3,5-DICHLOROPYRIDIN-4-YL)-4-(DIFLUOROMETHOXY)BENZAMIDE

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 13 USDMF, 6 EU WC, 4 KDMF, 10 NDC API, 17 Listed Suppliers, $ API Reference Price

26 API Suppliers
13 USDMF
6 EU WC
4 KDMF
10 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

84 Drugs in Development

84 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

47 FDF Dossiers, 23 FDA Orange Book, 14 Europe, 2 Canada, 1 South Africa, 7 Listed Dossiers

47 FDF Dossiers
23 FDA Orange Book
14 Europe
2 Canada
1 South Africa
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MCG, TABLET;ORAL - 500MCG

TABLET;ORAL - 250MCG
TABLET;ORAL - 500MCG

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 2 DFE Pharma, 1 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 15 Kerry, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 6 Roquette, 1 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 1 Ulanqab Kema New Material, 1 Vasa Pharmachem

3 SPI Pharma
4 Faran Shimi Pharmaceutical
1 Boai NKY Pharmaceuticals Ltd
9 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
9 BASF
2 DFE Pharma
1 Gangwal Chemicals
2 Ingredion Pharma Solutions
15 Kerry
8 Microlex e.U
1 Novo Excipients
1 Pharmatrans-Sanaq
4 Pluviaendo
1 Prachin Chemical
6 Roquette
1 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Sigachi Industries
1 Ulanqab Kema New Material
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders, 20 Direct Compression, 10 Granulation, 10 Co-Processed Excipients, 8 Lubricants & Glidants, 7 Solubilizers, 6 Disintegrants & Superdisintegrants, 5 Controlled & Modified Release, 4 Thickeners and Stabilizers, 3 Chewable & Orodispersible Aids, 3 Taste Masking, 3 Parenteral, 2 Coating Systems & Additives, 1 Emulsifying Agents, 1 Film Formers & Plasticizers

47 Fillers, Diluents & Binders
20 Direct Compression
10 Granulation
10 Co-Processed Excipients
8 Lubricants & Glidants
7 Solubilizers
6 Disintegrants & Superdisintegrants
5 Controlled & Modified Release
4 Thickeners and Stabilizers
3 Chewable & Orodispersible Aids
3 Taste Masking
3 Parenteral
2 Coating Systems & Additives
1 Emulsifying Agents
1 Film Formers & Plasticizers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 93 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
93 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 13 Finished Drug Prices, 10 Annual Reports

2 US Medicaid Prescriptions
13 Finished Drug Prices
10 Annual Reports

MARKET PLACE

13 APIs, 1 FDF Dossiers

13 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

45 US Patents, 4 US Exclusivities, 4 Health Canada Patents

45 US Patents
4 US Exclusivities
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

$ API Ref.Price (USD/KG) : 161,827 Xls

Filters

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23 All

01 2BRECKENRIDGE

02 2STRIDES PHARMA

03 2ALKEM LABS LTD

04 3ARCUTIS

05 2ASTRAZENECA

06 1AUROBINDO PHARMA LTD

07 2HETERO LABS LTD III

08 2MICRO LABS

09 2MSN

10 1MYLAN

11 1PRINSTON INC

12 1TORRENT

13 2ZYDUS PHARMS

filter Dosage Reset all filters

23 All

01 2CREAM;TOPICAL

02 1FOAM;TOPICAL

03 20TABLET;ORAL

filter Regulatory Info Reset all filters

23 All

01 3DISCN

02 20RX

filter Brand Name Reset all filters

23 All

01 2DALIRESP

02 18ROFLUMILAST

03 3ZORYVE

filter RLD Reset all filters

23 All

01 18No

02 5Yes

List of Suppliers

Product Main Page

01

BRECKENRIDGE

euroPLX 86 Munich

Not Confirmed

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Digital Content

RLD : No

TE Code :

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2018-10-03

Application Number : 208236

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

STRIDES PHARMA

CPhI India 2024

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2020-03-30

Application Number : 208247

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

Product Web Link

Digital Content

03

BRECKENRIDGE

euroPLX 86 Munich

Not Confirmed

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Digital Content

RLD : No

TE Code :

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-10-19

Application Number : 208236

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

STRIDES PHARMA

CPhI India 2024

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

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Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-06-20

Application Number : 208247

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

Product Web Link

Digital Content

05

ASTRAZENECA

euroPLX 86 Munich

Not Confirmed

ASTRAZENECA

euroPLX 86 Munich

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

ROFLUMILAST

Brand Name : DALIRESP

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2011-02-28

Application Number : 22522

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ASTRAZENECA

euroPLX 86 Munich

Not Confirmed

ASTRAZENECA

euroPLX 86 Munich

Not Confirmed

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Digital Content

RLD : Yes

TE Code : AB

ROFLUMILAST

Brand Name : DALIRESP

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2018-01-23

Application Number : 22522

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

HETERO LABS LTD III

euroPLX 86 Munich

Not Confirmed

HETERO LABS LTD III

euroPLX 86 Munich

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2018-11-23

Application Number : 208213

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

HETERO LABS LTD III

euroPLX 86 Munich

Not Confirmed

HETERO LABS LTD III

euroPLX 86 Munich

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-04-18

Application Number : 208213

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

MICRO LABS

euroPLX 86 Munich

Not Confirmed

MICRO LABS

euroPLX 86 Munich

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 500MCG

Approval Date : 2019-03-22

Application Number : 208180

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

MICRO LABS

euroPLX 86 Munich

Not Confirmed

MICRO LABS

euroPLX 86 Munich

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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Digital Content

RLD : No

TE Code : AB

ROFLUMILAST

Brand Name : ROFLUMILAST

Dosage Form : TABLET;ORAL

Dosage Strength : 250MCG

Approval Date : 2023-04-18

Application Number : 208180

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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