Akbeta

ANDA 74779, held by Epic Pharma LLC. Levobunolol Hydrochloride.

As of Nov 15, 2026, ANDA 74779 (Akbeta), held by Epic Pharma LLC, was first approved by FDA on Oct 29, 1996, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 29, 1996
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
Oct 29, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Akbeta0.25% · solution/drops;ophthalmic	Levobunolol Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 7, 1999	Supplement 1Manufacturing	Approved	None posted
Oct 29, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74779
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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