Is Aristocort still available?

Aristocort (NDA 011161) 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 A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.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 Aristocort have a generic?

Yes. The Orange Book lists 17 approved generic (ANDA) applications sharing Aristocort's active ingredient (Triamcinolone). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Aristocort's FDA application number?

Aristocort is approved under NDA 011161, held by Astellas.

Orange Book product · Brand (NDA)

Aristocort

Triamcinolone

Brand (NDA)NDA 011161Discontinued Astellas

Approved

Approved Prior to Jan 1, 1982

Application

Brand (NDA)

TE code

Not listed

Listed patents

Aristocort (Triamcinolone) is Astellas's brand-name drug, approved by the FDA under NDA 011161. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 17 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Active ingredient

TRIAMCINOLONE

Strength

4MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 011161

Product number

007

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 011161

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Triamcinolone 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.

Aristocort — 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 Triamcinolone active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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