Cefadroxil

ANDA 91036, held by Hikma Pharms. Cefadroxil/Cefadroxil Hemihydrate.

As of Nov 15, 2026, ANDA 91036 (Cefadroxil), held by Hikma Pharms, was first approved by FDA on Nov 28, 2012, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 28, 2012
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
Nov 28, 2012	Original application	Approved	None posted

Products

2 strengths and forms


CefadroxilEQ 250MG BASE/5ML · for suspension;oral	Cefadroxil/Cefadroxil Hemihydrate	Discontinued
CefadroxilEQ 500MG BASE/5ML · for suspension;oral	Cefadroxil/Cefadroxil Hemihydrate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 17, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Dec 17, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Nov 28, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 91036
Drugs@FDA: Overview at FDA
Company: Hikma 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