01 1Estradiol hemihydrate
02 3Progesteron
03 2Progesterone
04 6TESTOSTERONE
05 2progesterone
06 4testosterone
01 2BESINS HEALTHCARE IRELAND
02 6BESINS HLTHCARE
03 6Besins Healthcare Australia Pty Ltd
04 2Besins Healthcare Ireland Limited
05 1Besins Healthcare Ireland Limited (1)
06 1Besins Healthcare SA
01 2GEL, METERED;TRANSDERMAL
02 4GEL;TRANSDERMAL
03 2Soft Capsules
04 1Transdermal gel
05 3Vaginalkapsel, myk
06 4gel
07 2Blank
01 10.75 mg/dose
02 21% (12.5 mg/actuation
03 21% (50 mg/5 g
04 11.62% (20.25MG/1.25GM ACTUATION)
05 11.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
06 11.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
07 1100 mg
08 112.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
09 3200 mg
10 125MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
11 1300 mg
12 150MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
13 2Blank
01 6Australia
02 2Italy
03 4Norway
04 6USA
Regulatory Info :
Registration Country : Norway
Dosage Form : Transdermal gel
Brand Name : Estrogel
Dosage Strength : 0.75 mg/dose
Packaging : Plastic bottle with dose pump 1 80g
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Vaginalkapsel, myk
Brand Name : Utrogestan
Dosage Strength : 200 mg
Packaging : Blisterpakning 15item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Vaginalkapsel, myk
Brand Name : Utrogestan
Dosage Strength : 200 mg
Packaging : Blisterpakning 45item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Vaginalkapsel, myk
Brand Name : Utrogestan
Dosage Strength : 300 mg
Packaging : White plastic bottle 15item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Dosage Form : Soft Capsules
Brand Name : PROMETRIUM
Dosage Strength : 200 mg
Packaging : 15 UNITS 200 MG - ORAL OR VAGINAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Soft Capsules
Brand Name : PROMETRIUM
Dosage Strength : 100 mg
Packaging : 30 UNITS 100 MG - ORAL OR VAGINAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Australia
Dosage Form :
Brand Name : Utrogestan
Dosage Strength :
Packaging : 42
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form :
Brand Name : Utrogestan
Dosage Strength :
Packaging : 42
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : GEL;TRANSDERMAL
Brand Name : ANDROGEL
Dosage Strength : 50MG/5GM PACKET **Fede...
Packaging :
Approval Date : 2000-02-28
Application Number : 21015
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Australia
Dosage Form : gel
Brand Name : Testogel
Dosage Strength : 1% (50 mg/5 g
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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