Keflin In Plastic Container

ANDA 62549, held by Lilly. Cephalothin Sodium.

As of Nov 15, 2026, ANDA 62549 (Keflin In Plastic Container), held by Lilly, was first approved by FDA on Sep 10, 1985, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 10, 1985
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 10, 1985	Original application	Approved	None posted

Products

2 strengths and forms


Keflin In Plastic ContainerEQ 1GM BASE/VIAL · injectable;injection	Cephalothin Sodium	Discontinued
Keflin In Plastic ContainerEQ 2GM BASE/VIAL · injectable;injection	Cephalothin Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 30, 1992	Supplement 6Manufacturing	Approved	None posted
Sep 10, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 62549
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