Suprax

ANDA 65130, held by Lupin Pharms. Cefixime.

As of Nov 13, 2026, ANDA 65130 (Suprax), held by Lupin Pharms, was first approved by FDA on Feb 12, 2004, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 12, 2004
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 12, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Suprax400MG · tablet;oral	Cefixime	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 16, 2016	Supplement 18Labeling · Standard review	Approved	None posted
Mar 29, 2013	Supplement 16Labeling · Standard review	Approved	None posted
Jan 17, 2012	Supplement 4Labeling	Approved	None posted
Feb 12, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 65130
Drugs@FDA: Overview at FDA
Company: Lupin 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