Assyro AI

Orange Book product · Brand (NDA)

ACTIGALL

URSODIOL

Brand (NDA)NDA 019594TE ABRX TEVA BRANDED PHARM
View URSODIOL familyOpen on FDA Orange Book

At a glance

Dec 31, 1987

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 31, 1987

    39 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

URSODIOL

Strength

300MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 019594

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

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.

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