Lorabid

NDA 50667, held by King Pharms. Loracarbef.

As of Nov 14, 2026, NDA 50667 (Lorabid), held by King Pharms, was first approved by FDA on Dec 31, 1991, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1991
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Nov 13, 1996	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review
Dec 31, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Lorabid100MG/5ML · for suspension;oral	Loracarbef	Discontinued
Lorabid200MG/5ML · for suspension;oral	Loracarbef	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Sep 27, 2001	Supplement 22Labeling · Standard review	Approved	None posted
May 11, 2001	Supplement 20Labeling · Standard review	Approved	None posted
Oct 5, 2000	Supplement 18Labeling · Standard review	Approved	None posted
Sep 12, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 8, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 1, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Nov 26, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 13, 1996	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review
Nov 12, 1996	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 9, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 14, 1996	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 21, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 8, 1995	Supplement 8Labeling · Standard review	Approved	None posted
Feb 8, 1995	Supplement 9Labeling · Standard review	Approved	None posted
Jun 24, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 2, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 8, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 16, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 30, 1992	Supplement 2Labeling · Standard review	Approved	None posted
Dec 31, 1991	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50667
Drugs@FDA: Overview at FDA
Company: King 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