Product Details for NDA 022309
ANDROGEL (TESTOSTERONE)
1.62% (20.25MG/1.25GM ACTUATION)
Marketing Status: Prescription
1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1.62% (20.25MG/1.25GM ACTUATION)
Marketing Status: Prescription
Active Ingredient: TESTOSTERONE
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL, METERED; TRANSDERMAL
Strength: 1.62% (20.25MG/1.25GM ACTUATION)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022309
Product Number: 001
Approval Date: Apr 29, 2011
Applicant Holder Full Name: BESINS HEALTHCARE IRELAND LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ANDROGEL (TESTOSTERONE)
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL, METERED; TRANSDERMAL
Strength: 1.62% (20.25MG/1.25GM ACTUATION)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022309
Product Number: 001
Approval Date: Apr 29, 2011
Applicant Holder Full Name: BESINS HEALTHCARE IRELAND LTD
Marketing Status: Prescription
Patent and Exclusivity Information
1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TESTOSTERONE
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022309
Product Number: 002
Approval Date: Sep 7, 2012
Applicant Holder Full Name: BESINS HEALTHCARE IRELAND LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
ANDROGEL (TESTOSTERONE)
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022309
Product Number: 002
Approval Date: Sep 7, 2012
Applicant Holder Full Name: BESINS HEALTHCARE IRELAND LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TESTOSTERONE
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022309
Product Number: 003
Approval Date: Sep 7, 2012
Applicant Holder Full Name: BESINS HEALTHCARE IRELAND LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022309
Product Number: 003
Approval Date: Sep 7, 2012
Applicant Holder Full Name: BESINS HEALTHCARE IRELAND LTD
Marketing Status: Discontinued
Patent and Exclusivity Information