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Approved Drug Products containing acidum azelaicum listed in the FDA Orange Book. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 223Xls
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01 1TARO

02 1TARO PHARM INDS LTD

03 1ACTAVIS LABS UT INC

04 1ALMIRALL

05 1ENCUBE

06 1GLENMARK SPECLT

07 2LEO PHARMA AS

08 1TEVA PHARMS USA

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PharmaCompass

01

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Discovery on Target
Not Confirmed

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

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02

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Discovery on Target
Not Confirmed

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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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

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

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

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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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

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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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

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

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

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 :

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

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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09

GLENMARK SPECLT

Country
Discovery on Target
Not Confirmed
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GLENMARK SPECLT

Country
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Discovery on Target
Not Confirmed

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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