Is Actigall still available?

Yes. Actigall (NDA 019594) is listed with marketing status Prescription in the FDA Orange Book.

Does Actigall have a generic?

Yes. The Orange Book lists 22 approved generic (ANDA) applications sharing Actigall's active ingredient (Ursodiol). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Actigall's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Actigall substitutable for its reference brand with no expected difference in clinical effect.

What is Actigall's FDA application number?

Actigall is approved under NDA 019594, held by Teva Branded Pharm.

Orange Book product · Brand (NDA)

Actigall

Ursodiol

Brand (NDA)NDA 019594TE ABRLD Teva Branded Pharm

Approved

Dec 31, 1987

Application

Brand (NDA)

TE code

Listed patents

Actigall (Ursodiol) is Teva Branded Pharm's brand-name drug, approved by the FDA under NDA 019594 in 1987. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 22 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.
Dec 31, 1987
39 yr 1 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

URSODIOL

Strength

300MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 019594

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 019594

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE

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 Ursodiol 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.

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

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