Cefaclor

ANDA 64107, held by Dava Pharms Inc. Cefaclor.

As of Nov 13, 2026, ANDA 64107 (Cefaclor), held by Dava Pharms Inc, was first approved by FDA on Apr 27, 1995, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 27, 1995
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
Apr 27, 1995	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
CefaclorEQ 250MG BASE · capsule;oral	Cefaclor	Discontinued
CefaclorEQ 500MG BASE · capsule;oral	Cefaclor	Discontinued

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 6, 1996	Supplement 1Labeling	Approved	None posted
Apr 27, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 64107
Drugs@FDA: Overview at FDA
Company: DAVA Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters