Azelaic Acid | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Azelaic Acid
FDA Orange Book

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Azelaic Acid

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 8 USDMF, 4 EU WC, 1 KDMF, 9 NDC API, 8 Listed Suppliers, $ API Reference Price

23 API Suppliers
8 USDMF
4 EU WC
1 KDMF
9 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

FINISHED DOSAGE FORMULATIONS

28 FDF Dossiers, 9 FDA Orange Book, 14 Europe, 1 Canada, 2 South Africa, 2 Listed Dossiers

28 FDF Dossiers
9 FDA Orange Book
14 Europe
1 Canada
2 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 20%, AEROSOL, FOAM;TOPICAL - 15%, GEL;TOPICAL - 15%

CREAM;TOPICAL - 20%
AEROSOL, FOAM;TOPICAL - 15%
GEL;TOPICAL - 15%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 1 SPI Pharma, 1 Pharm-RX Chemical, 3 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 4 Kirsch Pharma, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 3 CD Formulation, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures, 1 Ingredion Pharma Solutions, 12 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 12 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 28 Fillers, Diluents & Binders, 28 Topical, 26 Thickeners and Stabilizers, 24 Controlled & Modified Release, 21 Solubilizers, 15 Disintegrants & Superdisintegrants, 15 Lubricants & Glidants, 14 Parenteral, 13 Film Formers & Plasticizers, 13 Direct Compression, 11 Granulation, 10 Emulsifying Agents, 8 Co-Processed Excipients, 7 API Stability Enhancers, 5 Empty Capsules, 5 Taste Masking, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Chewable & Orodispersible Aids, 2 Coloring Agents

45 Coating Systems & Additives
28 Fillers, Diluents & Binders
28 Topical
26 Thickeners and Stabilizers
24 Controlled & Modified Release
21 Solubilizers
15 Disintegrants & Superdisintegrants
15 Lubricants & Glidants
14 Parenteral
13 Film Formers & Plasticizers
13 Direct Compression
11 Granulation
10 Emulsifying Agents
8 Co-Processed Excipients
7 API Stability Enhancers
5 Empty Capsules
5 Taste Masking
5 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Chewable & Orodispersible Aids
2 Coloring Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 24 News #PharmaBuzz

2 Data Compilation #PharmaFlow
24 News #PharmaBuzz

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions, 3 Regulatory FDF Prices

7 US Medicaid Prescriptions
3 Regulatory FDF Prices

MARKET PLACE

14 APIs

14 APIs

PATENTS & EXCLUSIVITIES

4 US Patents, 1 Health Canada Patents

4 US Patents
1 Health Canada Patents

$ API Ref.Price (USD/KG) : 288 Xls

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filter Applicant Reset all filters

9 All

01 1ACTAVIS LABS UT INC

02 1ALMIRALL

03 1AUROBINDO PHARMA USA

04 1ENCUBE

05 1GLENMARK SPECLT

06 2LEO PHARMA AS

07 1SUN PHARMA CANADA

08 1TARO PHARM INDS LTD

filter Dosage Reset all filters

9 All

01 3AEROSOL, FOAM;TOPICAL

02 1CREAM;TOPICAL

03 5GEL;TOPICAL

filter Regulatory Info Reset all filters

9 All

01 1DISCN

02 7RX

03 1Blank

filter Brand Name Reset all filters

9 All

01 6AZELAIC ACID

02 1AZELEX

03 2FINACEA

filter RLD Reset all filters

9 All

01 5No

02 3Yes

03 1Blank

List of Suppliers

Product Main Page

01

ACTAVIS LABS UT INC

PharmaSynergy

Not Confirmed

ACTAVIS LABS UT INC

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Digital Content

RLD : No

TE Code : AB

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Approval Date : 2018-11-19

Application Number : 208011

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

ALMIRALL

PharmaSynergy

Not Confirmed

ALMIRALL

PharmaSynergy

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Digital Content

RLD : Yes

TE Code :

AZELAIC ACID

Brand Name : AZELEX

Dosage Form : CREAM;TOPICAL

Dosage Strength : 20%

Approval Date : 1995-09-13

Application Number : 20428

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

AUROBINDO PHARMA USA

PharmaSynergy

Not Confirmed

AUROBINDO PHARMA USA

PharmaSynergy

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Digital Content

RLD : No

TE Code :

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : AEROSOL, FOAM;TOPICAL

Dosage Strength : 15%

Approval Date : 2020-10-07

Application Number : 210928

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

ENCUBE

PharmaSynergy

Not Confirmed

ENCUBE

PharmaSynergy

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RLD : No

TE Code : AB

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Approval Date : 2018-11-19

Application Number : 208724

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

GLENMARK SPECLT

PharmaSynergy

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GLENMARK SPECLT

PharmaSynergy

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RLD : No

TE Code : AB

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Approval Date : 2018-11-19

Application Number : 204637

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

LEO PHARMA AS

PharmaSynergy

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LEO PHARMA AS

PharmaSynergy

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RLD : Yes

TE Code : AB

AZELAIC ACID

Brand Name : FINACEA

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Approval Date : 2002-12-24

Application Number : 21470

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

LEO PHARMA AS

PharmaSynergy

Not Confirmed

LEO PHARMA AS

PharmaSynergy

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RLD : Yes

TE Code :

AZELAIC ACID

Brand Name : FINACEA

Dosage Form : AEROSOL, FOAM;TOPICAL

Dosage Strength : 15%

Approval Date : 2015-07-29

Application Number : 207071

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

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08

SUN PHARMA CANADA

PharmaSynergy

Not Confirmed

SUN PHARMA CANADA

PharmaSynergy

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RLD : No

TE Code : AB

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Approval Date : 2019-08-23

Application Number : 210549

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

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09

TARO PHARM INDS LTD

PharmaSynergy

Not Confirmed

TARO PHARM INDS LTD

PharmaSynergy

Not Confirmed

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RLD :

TE Code :

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : AEROSOL, FOAM;TOPICAL

Dosage Strength : 15%

Approval Date :

Application Number : 212581

RX/OTC/DISCN :

RLD :

TE Code :

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.