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
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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

48 FDF Dossiers, 24 FDA Orange Book, 14 Europe, 2 Canada, 1 South Africa, 7 Listed Dossiers

48 FDF Dossiers
24 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, 2 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 Vasa Pharmachem

3 SPI Pharma
4 Faran Shimi Pharmaceutical
1 Boai NKY Pharmaceuticals Ltd
9 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
2 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 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 19 Direct Compression, 10 Granulation, 10 Co-Processed Excipients, 8 Lubricants & Glidants, 6 Solubilizers, 5 Disintegrants & Superdisintegrants, 5 Controlled & Modified Release, 4 Thickeners and Stabilizers, 3 Taste Masking, 3 Parenteral, 3 Chewable & Orodispersible Aids, 2 Coating Systems & Additives, 1 Emulsifying Agents, 1 Film Formers & Plasticizers

46 Fillers, Diluents & Binders
19 Direct Compression
10 Granulation
10 Co-Processed Excipients
8 Lubricants & Glidants
6 Solubilizers
5 Disintegrants & Superdisintegrants
5 Controlled & Modified Release
4 Thickeners and Stabilizers
3 Taste Masking
3 Parenteral
3 Chewable & Orodispersible Aids
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) : 158,313 Xls

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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 2TORRENT

13 2ZYDUS PHARMS

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24 All

01 2CREAM;TOPICAL

02 1FOAM;TOPICAL

03 21TABLET;ORAL

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24 All

01 3DISCN

02 21RX

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24 All

01 2DALIRESP

02 19ROFLUMILAST

03 3ZORYVE

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24 All

01 19No

02 5Yes

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BRECKENRIDGE

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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

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STRIDES PHARMA

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

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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

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03

BRECKENRIDGE

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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

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STRIDES PHARMA

Antibody Engineering

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

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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

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05

ASTRAZENECA

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ASTRAZENECA

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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

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ASTRAZENECA

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ASTRAZENECA

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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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HETERO LABS LTD III

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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

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08

HETERO LABS LTD III

Antibody Engineering

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HETERO LABS LTD III

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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

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09

MICRO LABS

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MICRO LABS

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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

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10

MICRO LABS

Antibody Engineering

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MICRO LABS

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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

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