Norpace Cr

NDA 18655, held by Pfizer. Disopyramide Phosphate.

As of Nov 14, 2026, NDA 18655 (Norpace Cr), held by Pfizer, was first approved by FDA on Jul 20, 1982, with 31 approved supplements and 0 published complete response letters.

First approved: Jul 20, 1982
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below


Jul 3, 1991	Supplement 26Efficacy (new indication or use)	Approved	None posted
Jun 19, 1985	Supplement 8Efficacy (new indication or use)	Approved	None posted
Jul 20, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Norpace CrEQ 100MG BASE · capsule, extended release;oral	Disopyramide Phosphate	DiscontinuedReference drug
Norpace CrEQ 150MG BASE · capsule, extended release;oral	Disopyramide Phosphate	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


May 17, 2000	Supplement 33Labeling · Standard review	Approved	None posted
Nov 10, 1998	Supplement 32Labeling · Standard review	Approved	None posted
Jul 17, 1998	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 3, 1998	Supplement 30Labeling · Standard review	Approved	None posted
Jan 13, 1997	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 28, 1996	Supplement 28Labeling · Standard review	Approved	None posted
Dec 21, 1993	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 16, 1992	Supplement 25Labeling	Approved	None posted
Jul 3, 1991	Supplement 26Efficacy (new indication or use)	Approved	None posted
Nov 16, 1989	Supplement 24Labeling	Approved	None posted
Oct 20, 1989	Supplement 23Labeling	Approved	None posted
Feb 4, 1988	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 28, 1987	Supplement 21Labeling	Approved	None posted
Jun 30, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 21, 1987	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 12, 1987	Supplement 19Labeling	Approved	None posted
May 30, 1986	Supplement 16Labeling	Approved	None posted
May 6, 1986	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 26, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 19, 1985	Supplement 11Labeling	Approved	None posted
Jun 19, 1985	Supplement 8Efficacy (new indication or use)	Approved	None posted
Jun 19, 1985	Supplement 4Labeling	Approved	None posted
Jun 18, 1985	Supplement 13Labeling	Approved	None posted
Jan 25, 1985	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 29, 1984	Supplement 10Labeling	Approved	None posted
Oct 19, 1983	Supplement 9Labeling	Approved	None posted
Sep 6, 1983	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 10, 1983	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 10, 1983	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 22, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 21, 1982	Supplement 1Labeling	Approved	None posted
Jul 20, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18655
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters