Bimatoprost

ANDA 201894, held by Apotex. Bimatoprost.

First approved: Dec 1, 2014
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
Dec 1, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Bimatoprost0.03% · solution/drops;topical	Bimatoprost	Discontinued

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 3, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Aug 3, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Dec 10, 2018	Supplement 3Manufacturing	Approved	None posted
Dec 1, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 201894
Drugs@FDA: Overview at FDA
Company: Apotex

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