Orange Book product · Brand (NDA)

DYNACIRC

ISRADIPINE

Brand (NDA)NDA 019546DISCN SMITHKLINE BEECHAM

View ISRADIPINE family Open on FDA Orange Book

At a glance

Dec 20, 1990

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 20, 1990
36 yr ago
Today

Pharmaceutical detail

Active ingredient

ISRADIPINE

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 019546

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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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