Orange Book product · Brand (NDA)

NORPACE CR

DISOPYRAMIDE PHOSPHATE

Brand (NDA)NDA 018655RX PFIZER

View DISOPYRAMIDE PHOSPHATE family Open on FDA Orange Book

At a glance

Jul 20, 1982

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jul 20, 1982
44 yr 7 mo ago
Today

Pharmaceutical detail

Active ingredient

DISOPYRAMIDE PHOSPHATE

Strength

EQ 150MG BASE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 018655

Product number

002

Marketing status

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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