DIPRIVAN

FDA-1998-P-0974

Zeneca Inc. filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA withdraw approval of the portions of NDA 19-627 providing for DIPRIVAN (propofol) Injectable Emulsion without the antimicrobial additive disodium edetate, pursuant to Section 505(e) of the Federal Food, Drug, and

FDA-2005-P-0059

The American College of Gastroenterology filed this citizen petition on June 27, 2005, pursuant to 21 C.F.R. § 10.30, requesting that the FDA remove the warning from propofol (Diprivan) labeling that restricts its administration to persons trained in general anesthesia, arguing that substantial clin

FDA-2005-P-0059

The American College of Gastroenterology filed this citizen petition on June 27, 2005, requesting that the FDA remove a warning from propofol (Diprivan) labeling that restricts its administration to persons trained in general anesthesia, arguing that substantial clinical evidence demonstrates gastro

FDA-1998-P-0262

Phoenix Scientific Inc. filed this suitability petition under Federal Food, Drug, and Cosmetic Act Section 512(n)(3) on December 3, 1998, requesting permission to file an Abbreviated New Animal Drug Application for a generic propofol injection at a different concentration (100 mg/mL versus the appro

FDA-2000-P-1219

GensiaSicor Pharmaceuticals filed an ANDA Suitability Petition under Section 505(j)(2)(c) requesting permission to submit an abbreviated new drug application for Propofol Injectable Emulsion 2% in 10 mL and 50 mL single-use vials, which would deliver the same drug amount as the reference listed drug

FDA-1999-P-1293

Veterinary Research Associates, Inc filed this citizen petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act seeking permission to file an Abbreviated New Animal Drug Application for a generic propofol anesthetic injection that differs from the innovator product PropoFlo (10 m

FDA-1998-P-0677

Gensia Sicor Pharmaceuticals filed an ANDA Suitability Petition (Docket No. 98P-00069/CP1) in February 1998 for Propofol Injectable Emulsion 10 mg/mL in pre-filled syringes but subsequently withdrew the petition at the FDA's request after being informed that a suitability petition was not required f

FDA-1998-P-0677

GensiaSicor Pharmaceuticals filed this ANDA Suitability Petition under 21 CFR 314.93 on February 6, 1998, requesting permission to submit an abbreviated new drug application for Propofol Injectable Emulsion 1% formulated without the preservative disodium edetate, supplied as a single-use 20 mL pre-f

FDA-2006-P-0020

Foley & Lardner LLP filed this citizen petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA investigate Bedford Laboratories' Propofol Injectable Emulsion, approved under ANDA 75-858 as a generic version of the reference drug Diprivan (NDA 19-