Lorabid

NDA 50668, held by King Pharms. Loracarbef.

As of Nov 13, 2026, NDA 50668 (Lorabid), held by King Pharms, was first approved by FDA on Dec 31, 1991, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1991
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Nov 13, 1996	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review
Dec 31, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Lorabid200MG · capsule;oral	Loracarbef	Discontinued
Lorabid400MG · capsule;oral	Loracarbef	Discontinued

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 11, 2001	Supplement 22Labeling · Standard review	Approved	None posted
Nov 29, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 5, 2000	Supplement 19Labeling · Standard review	Approved	None posted
Jul 27, 2000	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 8, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 18, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 26, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 13, 1996	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review
May 15, 1996	Supplement 16Labeling · Standard review	Approved	None posted
Apr 25, 1996	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 25, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 5, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Jan 25, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 14, 1995	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 30, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 7, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 22, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 17, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 30, 1992	Supplement 3Labeling · Standard review	Approved	None posted
Mar 30, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 31, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50668
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