Propofol

ANDA 205307, held by Watson Labs Inc. Propofol.

As of Nov 13, 2026, ANDA 205307 (Propofol), held by Watson Labs Inc, was first approved by FDA on Dec 22, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2015
Review: Standard
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
Dec 22, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Propofol10MG/ML · injectable;injection	Propofol	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 30, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Nov 8, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 22, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 205307
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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