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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020489

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ANDRODERM (TESTOSTERONE)
2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TESTOSTERONE
Proprietary Name: ANDRODERM
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020489
Product Number: 003
Approval Date: Oct 20, 2011
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ANDRODERM (TESTOSTERONE)
2.5MG/24HR
Marketing Status: Discontinued
Active Ingredient: TESTOSTERONE
Proprietary Name: ANDRODERM
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 2.5MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020489
Product Number: 001
Approval Date: Sep 29, 1995
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ANDRODERM (TESTOSTERONE)
4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TESTOSTERONE
Proprietary Name: ANDRODERM
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020489
Product Number: 004
Approval Date: Oct 20, 2011
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ANDRODERM (TESTOSTERONE)
5MG/24HR
Marketing Status: Discontinued
Active Ingredient: TESTOSTERONE
Proprietary Name: ANDRODERM
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 5MG/24HR
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020489
Product Number: 002
Approval Date: May 2, 1997
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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