Keflin

NDA 50482, held by Lilly. Cephalothin Sodium.

As of Nov 13, 2026, NDA 50482 (Keflin), held by Lilly, was first approved by FDA on Dec 18, 1974, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1974
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Nov 25, 1985	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 18, 1974	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
KeflinEQ 1GM BASE/VIAL · injectable;injection	Cephalothin Sodium	Discontinued
KeflinEQ 2GM BASE/VIAL · injectable;injection	Cephalothin Sodium	Discontinued
KeflinEQ 4GM BASE/VIAL · injectable;injection	Cephalothin Sodium	Discontinued
KeflinEQ 20GM BASE/VIAL · injectable;injection	Cephalothin Sodium	Discontinued

All 23 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 19, 1993	Supplement 27Labeling · Standard review	Approved	None posted
Mar 20, 1987	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 30, 1986	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 17, 1985	Supplement 19Labeling · Standard review	Approved	None posted
Nov 25, 1985	Supplement 18Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 7, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
May 8, 1985	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 7, 1984	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 8, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 5, 1983	Supplement 13Labeling · Standard review	Approved	None posted
Oct 5, 1983	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 24, 1983	Supplement 11Labeling · Standard review	Approved	None posted
Aug 5, 1983	Supplement 10Labeling · Standard review	Approved	None posted
Aug 5, 1983	Supplement 9Labeling · Standard review	Approved	None posted
Jun 21, 1983	Supplement 8Labeling · Standard review	Approved	None posted
Jun 20, 1983	Supplement 7Labeling · Standard review	Approved	None posted
Mar 18, 1983	Supplement 6Labeling · Standard review	Approved	None posted
Mar 8, 1983	Supplement 5Labeling · Standard review	Approved	None posted
Feb 17, 1983	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 1, 1983	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 13, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 17, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 18, 1974	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50482
Drugs@FDA: Overview at FDA
Company: Lilly

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