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01 1Actavis Inc
02 2Adcock Ingram
03 1Almirall
04 2Bayer AG
05 1Ebb Medical
06 1Encube Ethicals
07 1Glenmark Pharmaceuticals
08 1INTENDIS SpA
09 6Leo Pharma
10 2T.M.Thakore Pharmaceutical Laboratories
11 2Taro Pharmaceutical Industries
12 1Teva Pharmaceutical Industries
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01 3AEROSOL, FOAM;TOPICAL
02 1CREAM;TOPICAL
03 1CRO
04 3Cream
05 2GEL
06 5GEL;TOPICAL
07 3Gel
08 2Topical Solution
09 1Blank
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01 1Allowed
02 2Approved
03 1DISCN
04 1Deregistered
05 2Originator
06 7RX
07 7Blank
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01 6AZELAIC ACID
02 1AZELEX
03 3FINACEA
04 4Finacea
05 3Skinoren
06 1Skinoren Acne Cream
07 1Skinoren Gel
08 2Blank
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01 1Canada
02 2India
03 1Italy
04 2Norway
05 2South Africa
06 3Sweden
07 1Switzerland
08 9USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : Originator
Registration Country : South Africa
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
Regulatory Info : Originator
Registration Country : South Africa
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : Norway
Brand Name : Finacea
Dosage Form : Gel
Dosage Strength : 15%
Packaging : Tube
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Skinoren
Dosage Form : Cream
Dosage Strength : 20%
Packaging : Tube
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Finacea
Dosage Form : Gel
Dosage Strength : 15%
Packaging :
Approval Date : 11/09/2019
Application Number : 2.01904E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : Canada
Brand Name : FINACEA
Dosage Form : GEL
Dosage Strength : 15%/W/W
Packaging :
Approval Date :
Application Number : 2270811
Regulatory Info :
Registration Country : Canada
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Finacea
Dosage Form : Gel
Dosage Strength : 15%
Packaging :
Approval Date : 17/12/2002
Application Number : 2.00212E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Skinoren
Dosage Form : Cream
Dosage Strength : 20%
Packaging :
Approval Date : 20/03/1992
Application Number : 1.99203E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : India
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
Regulatory Info :
Registration Country : India
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : USA
Brand Name : AZELAIC ACID
Dosage Form : AEROSOL, FOAM;TOPICAL
Dosage Strength : 15%
Packaging :
Approval Date :
Application Number : 212581
Regulatory Info :
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info :
Registration Country : Italy
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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