Is Androderm still available?

Androderm (NDA 020489) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Androderm have a generic?

Yes. The Orange Book lists 26 approved generic (ANDA) applications sharing Androderm's active ingredient (Testosterone). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Androderm's FDA application number?

Androderm is approved under NDA 020489, held by Abbvie.

Orange Book product · Brand (NDA)

Androderm

Testosterone

Brand (NDA)NDA 020489DiscontinuedRLD Abbvie

Approved

Oct 20, 2011

Application

Brand (NDA)

TE code

Not listed

Listed patents

Androderm (Testosterone) is Abbvie's brand-name drug, approved by the FDA under NDA 020489 in 2011. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 26 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 20, 2011
14 yr 11 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

TESTOSTERONE

Strength

4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 020489

Product number

004

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 020489

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Testosterone family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Androderm — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Testosterone active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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