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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 7Leo Pharma
10 2T.M.Thakore Pharmaceutical Laboratories
11 2Taro Pharmaceutical Industries
12 1Teva Pharmaceutical Industries
13 1Vinas
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01 3AEROSOL, FOAM;TOPICAL
02 1CREAM;TOPICAL
03 1CRO
04 4Cream
05 2GEL
06 5GEL;TOPICAL
07 4Gel
08 2Topical Solution
09 1Blank
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01 1Allowed
02 2Approved
03 2Authorized
04 1DISCN
05 1Deregistered
06 2Originator
07 1Prescription
08 7RX
09 6Blank
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01 6AZELAIC ACID
02 1AZELEX
03 3FINACEA
04 5Finacea
05 3Skinoren
06 1Skinoren Acne Cream
07 1Skinoren Gel
08 1Zeliderm
09 2Blank
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01 1Canada
02 2India
03 1Italy
04 2Norway
05 2South Africa
06 2Spain
07 3Sweden
08 1Switzerland
09 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 : 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 : 20190430000016
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 : Approved
Registration Country : Sweden
Brand Name : Finacea
Dosage Form : Gel
Dosage Strength : 15%
Packaging :
Approval Date : 17/12/2002
Application Number : 20021217000496
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 : 19920320000017
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Skinoren
Dosage Form : Cream
Dosage Strength : 200mg
Packaging :
Approval Date : 13/03/1990
Application Number : 50262
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : FINACEA
Dosage Form : GEL
Dosage Strength : 15%/W/W
Packaging :
Approval Date :
Application Number : 2270811
Regulatory Info : Prescription
Registration Country : Canada
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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