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 are sixty-nine drug master file entries for this compound. Eighteen 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EXTENDED RELEASE;TRANSDERMAL			Strength	2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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	⤷ Sign Up	⤷ Sign Up
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-001	Sep 29, 1995	⤷ Sign Up	⤷ Sign Up
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	⤷ Sign Up	⤷ Sign Up
Abbvie	ANDRODERM	testosterone	FILM, EXTENDED RELEASE;TRANSDERMAL	020489-002	May 2, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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