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Generated: April 18, 2019

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Details for New Drug Application (NDA): 020489

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NDA 020489 describes ANDRODERM, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from two suppliers. 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. Seventeen suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 020489
Tradename:ANDRODERM
Applicant:Allergan Sales Llc
Ingredient:testosterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020489
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 020489
Suppliers and Packaging for NDA: 020489
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489 NDA Allergan, Inc. 0023-5990 0023-5990-60 60 POUCH in 1 CARTON (0023-5990-60) > 1 PATCH in 1 POUCH > 1 d in 1 PATCH
ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489 NDA Allergan, Inc. 0023-5992 0023-5992-30 30 POUCH in 1 CARTON (0023-5992-30) > 1 PATCH in 1 POUCH > 1 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength2.5MG/24HR
Approval Date:Sep 29, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MG/24HR
Approval Date:May 2, 1997TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength2MG/24HR
Approval Date:Oct 20, 2011TE:RLD:Yes

Expired US Patents for NDA 020489

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-002 May 2, 1997 ➤ Sign Up ➤ Sign Up
Allergan Sales Llc ANDRODERM testosterone FILM, EXTENDED RELEASE;TRANSDERMAL 020489-001 Sep 29, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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