Last Updated: September 28, 2026

Details for New Drug Application (NDA): 020489

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NDA 020489 describes ANDRODERM, which is a drug marketed by Abbvie and is included in one NDA. Additional details are available on the ANDRODERM profile page.

The generic ingredient in ANDRODERM is testosterone. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

Summary for 020489

Tradename:	ANDRODERM
Applicant:	Abbvie
Ingredient:	testosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 020489

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	2.5MG/24HR
Approval Date:	Sep 29, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	5MG/24HR
Approval Date:	May 2, 1997	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 20, 2011	TE:		RLD:	Yes

Expired US Patents for NDA 020489

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	⤷ Start Trial	⤷ Start Trial
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	⤷ Start Trial	⤷ Start Trial
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	⤷ Start Trial	⤷ Start Trial
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	⤷ Start Trial	⤷ Start Trial
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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