01 22care4
02 12care4 ApS
03 3Alphapharm PTY Ltd
04 1Apotex Inc
05 1BRUNO FARMACEUTICI SpA
06 1Barr Laboratories
07 1Forest Laboratories
08 1Glenmark Pharmaceuticals
09 1Medartuum AB
10 2Merck & Co
11 1Merck Group
12 1Merck Sante SAS
13 2Merck Santé s.a.s.
14 3ORIFARM GROUP AS
15 1Paranova Group AS
16 2Pharmachim AB
17 2Viatris
18 1Zydus Pharmaceuticals
01 1Acamprosate 333Mg 84 Combined Oral Use
02 4Enteric Tablet
03 1Film-Coated Tablets
04 1Filmtablet
05 9GASTRO
06 1TAB
07 1TABLET (DELAYED-RELEASE)
08 5TABLET, DELAYED RELEASE;ORAL
09 1Tablet
10 3Blank
01 3DISCN
02 1Originator
03 1Prescription
04 2RX
05 20Blank
01 4ACAMPROSATE CALCIUM
02 1ACAMPROSATE VIATRIS
03 1APO-Acamprosate
04 2Aotal
05 1Besobrial
06 2CAMPRAL
07 16Campral
01 4Australia
02 1Canada
03 1Italy
04 4Norway
05 1South Africa
06 9Sweden
07 2Switzerland
08 5USA
Regulatory Info :
Registration Country : Australia
Brand Name : Campral
Dosage Form : Tablet
Dosage Strength : 333mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Campral
Dosage Form :
Dosage Strength :
Packaging : 180
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : ACAMPROSATE VIATRIS
Dosage Form :
Dosage Strength :
Packaging : 180
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : APO-Acamprosate
Dosage Form :
Dosage Strength :
Packaging : 180
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ACAMPROSATE CALCIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : 333MG
Packaging :
Approval Date : 2013-11-18
Application Number : 200143
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CAMPRAL
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2004-07-29
Application Number : 21431
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ACAMPROSATE CALCIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : 333MG
Packaging :
Approval Date : 2013-07-16
Application Number : 202229
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Campral
Dosage Form : Film-Coated Tablets
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Campral
Dosage Form : Filmtablet
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Besobrial
Dosage Form : TAB
Dosage Strength : 333mg
Packaging : 180X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Sweden
Brand Name : Campral
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Aotal
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Campral
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Campral
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Campral
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : RX
Registration Country : USA
Brand Name : ACAMPROSATE CALCIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : 333MG
Packaging :
Approval Date : 2014-03-11
Application Number : 200142
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : CAMPRAL
Dosage Form : TABLET (DELAYED-RELEASE)
Dosage Strength : 333MG
Packaging : 84
Approval Date :
Application Number : 2293269
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : ACAMPROSATE CALCIUM
Dosage Form : TABLET, DELAYED RELEASE;ORAL
Dosage Strength : 333MG
Packaging :
Approval Date : 2017-05-26
Application Number : 205995
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Aotal
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Campral
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Campral
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Campral
Dosage Form : GASTRO
Dosage Strength : 333 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Campral
Dosage Form : Acamprosate 333Mg 84 Combined Oral Use
Dosage Strength : 84 cpr riv gastrores 333 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Campral
Dosage Form : Enteric Tablet
Dosage Strength : 333 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Campral
Dosage Form : Enteric Tablet
Dosage Strength : 333 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Campral
Dosage Form : Enteric Tablet
Dosage Strength : 333 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Campral
Dosage Form : Enteric Tablet
Dosage Strength : 333 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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