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01 2Taro Pharmaceutical Industries

02 1Actavis Inc

03 2Adcock Ingram

04 1Almirall

05 4Bayer AG

06 1Encube Ethicals

07 1GLENMARK SPECLT

08 1INTENDIS SpA

09 4Leo Pharma

10 2T.M.Thakore Pharmaceutical Laboratories

11 1Teva Pharmaceutical Industries

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PharmaCompass

01

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American Pharma Summit
Not Confirmed

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date : 2019-08-23

Application Number : 210549

Regulatory Info : RX

Registration Country : USA

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02

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American Pharma Summit
Not Confirmed

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : AEROSOL, FOAM;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date :

Application Number : 212581

Regulatory Info :

Registration Country : USA

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03

American Pharma Summit
Not Confirmed
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American Pharma Summit
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AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date : 2018-11-19

Application Number : 208011

Regulatory Info : RX

Registration Country : USA

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04

American Pharma Summit
Not Confirmed
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American Pharma Summit
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Azelaic Acid

Brand Name : Skinoren Gel

Dosage Form : GEL

Dosage Strength : 10mg/g

Packaging : 30X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

American Pharma Summit
Not Confirmed
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American Pharma Summit
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Azelaic Acid

Brand Name : Skinoren Acne Cream

Dosage Form : CRO

Dosage Strength : 10mg/g

Packaging : 30X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

American Pharma Summit
Not Confirmed
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American Pharma Summit
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AZELAIC ACID

Brand Name : AZELEX

Dosage Form : CREAM;TOPICAL

Dosage Strength : 20%

Packaging :

Approval Date : 1995-09-13

Application Number : 20428

Regulatory Info : RX

Registration Country : USA

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07

American Pharma Summit
Not Confirmed
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American Pharma Summit
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azelaic acid

Brand Name : Finacea

Dosage Form : GEL

Dosage Strength : 15%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

American Pharma Summit
Not Confirmed
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American Pharma Summit
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azelaic acid

Brand Name : Skinoren

Dosage Form : CREAM

Dosage Strength : 20%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

American Pharma Summit
Not Confirmed
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American Pharma Summit
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Azelaic Acid

Brand Name : Finacea

Dosage Form : Gel

Dosage Strength : 15%

Packaging : Tube

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

Azelaic Acid

Brand Name : Skinoren

Dosage Form : Cream

Dosage Strength : 20%

Packaging : Tube

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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11

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date : 2018-11-19

Application Number : 208724

Regulatory Info : RX

Registration Country : USA

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12

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

AZELAIC ACID

Brand Name : FINACEA

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date : 2002-12-24

Application Number : 21470

Regulatory Info : RX

Registration Country : USA

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13

American Pharma Summit
Not Confirmed
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American Pharma Summit
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AZELAIC ACID

Brand Name : FINACEA

Dosage Form : AEROSOL, FOAM;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date : 2015-07-29

Application Number : 207071

Regulatory Info : RX

Registration Country : USA

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14

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

Acidum azelaicum

Brand Name : Skinoren

Dosage Form : Cream

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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15

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

AZELAIC ACID

Brand Name : FINACEA

Dosage Form : GEL

Dosage Strength : 15%/W/W

Packaging :

Approval Date :

Application Number : 2270811

Regulatory Info : Prescription

Registration Country : Canada

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16

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

Minoxidil; Tretinoin; Azelaic Acid; alcohol

Brand Name :

Dosage Form : Topical Solution

Dosage Strength : 2%; 0.010%; 1.5%; 65%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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17

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

Minoxidil; Tretinoin; Azelaic Acid; alcohol

Brand Name :

Dosage Form : Topical Solution

Dosage Strength : 5%; 0.010%; 1.5%; 38%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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18

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : AEROSOL, FOAM;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date : 2020-10-07

Application Number : 210928

Regulatory Info : DISCN

Registration Country : USA

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19

GLENMARK SPECLT

Country
American Pharma Summit
Not Confirmed
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GLENMARK SPECLT

Country
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American Pharma Summit
Not Confirmed

AZELAIC ACID

Brand Name : AZELAIC ACID

Dosage Form : GEL;TOPICAL

Dosage Strength : 15%

Packaging :

Approval Date : 2018-11-19

Application Number : 204637

Regulatory Info : RX

Registration Country : USA

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20

INTENDIS SpA

Country
American Pharma Summit
Not Confirmed
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INTENDIS SpA

Country
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American Pharma Summit
Not Confirmed

Azelaic Acid

Brand Name : Finacea

Dosage Form :

Dosage Strength : Gel 30 G 15 %  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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