Cephalothin Sodium W/ Dextrose In Plastic Container

ANDA 62730, held by Baxter Hlthcare. Cephalothin Sodium.

As of Nov 15, 2026, ANDA 62730 (Cephalothin Sodium W/ Dextrose In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Mar 5, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 5, 1987
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 5, 1987	Original application	Approved	None posted

Products

2 strengths and forms


Cephalothin Sodium W/ Dextrose In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Cephalothin Sodium	Discontinued
Cephalothin Sodium W/ Dextrose In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Cephalothin Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Nov 12, 1992	Supplement 2Labeling	Approved	None posted
Mar 25, 1992	Supplement 1Labeling	Approved	None posted
Mar 5, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 62730
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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