Pce

NDA 50611, held by Azurity. Erythromycin.

As of Nov 13, 2026, NDA 50611 (Pce), held by Azurity, was first approved by FDA on Sep 9, 1986, with 24 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1986
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Sep 9, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Pce333MG · tablet, coated particles;oral	Erythromycin	DiscontinuedReference drug
Pce500MG · tablet, coated particles;oral	Erythromycin	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements


Apr 23, 2018	Supplement 36Labeling · Standard review	Approved	Label Letter
Feb 2, 2012	Supplement 35Labeling · Standard review	Approved	Label Letter
Jan 27, 2011	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 4, 2010	Supplement 31Labeling · Standard review	Approved	Letter
Dec 10, 2008	Supplement 32Labeling · Standard review	Approved	Label Letter
May 22, 2008	Supplement 30Labeling · Standard review	Approved	Letter
Jan 5, 2008	Supplement 29Labeling · Standard review	Approved	Letter Label
Aug 9, 2006	Supplement 22Labeling · Standard review	Approved	Letter Label
Mar 12, 2004	Supplement 24Labeling · Standard review	Approved	Letter
Apr 25, 2002	Supplement 19Labeling · Standard review	Approved	Letter
Feb 4, 2000	Supplement 18Labeling · Standard review	Approved	Review
May 14, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 14, 1997	Supplement 16Labeling · Standard review	Approved	None posted
May 18, 1993	Supplement 12Labeling	Approved	None posted
Aug 22, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 25, 1989	Supplement 9Bioequivalence · Standard review	Approved	None posted
Sep 25, 1989	Supplement 2Bioequivalence · Standard review	Approved	None posted
Sep 25, 1989	Supplement 1Bioequivalence · Standard review	Approved	None posted
Jan 5, 1988	Supplement 14Labeling	Approved	None posted
Oct 8, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 13, 1987	Supplement 6Labeling	Approved	None posted
May 20, 1987	Supplement 13Manufacturing · Standard review	Approved	None posted
May 15, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 4, 1987	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 9, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50611
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

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

Pce