Bimatoprost

ANDA 202565, held by Sandoz. Bimatoprost.

First approved: May 5, 2015
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
May 5, 2015	Original application	Approved	Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bimatoprost0.03% · solution/drops;ophthalmic	Bimatoprost	Rx

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 1, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Dec 1, 2022	Supplement 1Labeling · Standard review	Approved	None posted
May 5, 2015	Original application	Approved	Letter Label

Identifiers

Application: ANDA 202565
Drugs@FDA: Overview at FDA
Company: Sandoz

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