Is Asacol Hd still available?

Asacol Hd (NDA 021830) 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 A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.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 Asacol Hd have a generic?

Yes. The Orange Book lists 35 approved generic (ANDA) applications sharing Asacol Hd's active ingredient (Mesalamine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Asacol Hd's FDA application number?

Asacol Hd is approved under NDA 021830, held by Abbvie.

Orange Book product · Brand (NDA)

Asacol Hd

Mesalamine

Brand (NDA)NDA 021830DiscontinuedRLD Abbvie

Approved

May 29, 2008

Application

Brand (NDA)

TE code

Not listed

Listed patents

Asacol Hd (Mesalamine) is Abbvie's brand-name drug, approved by the FDA under NDA 021830 in 2008. 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 Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 35 approved generics share this drug's active ingredient.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.
May 29, 2008
18 yr 5 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

MESALAMINE

Strength

800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 021830

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

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 Mesalamine 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.

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

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