PROPOFOL | A075102 | SAGENT PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Zeneca Inc - Citizen Petition FDA-1998-P-0974 · 10 docket documents 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 | Other | 2009-11-17 | Denied | — |
American College of Gastroenterology - Citizen Petition FDA-2005-P-0059 · 9 docket documents 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 | Other | 2009-10-08 | Denied | — |
Citizen Petition from Phoenix Scientific Inc. FDA-1998-P-0262 · 4 docket documents 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 | Other | 2009-10-08 | Denied | Phoenix Scientific Inc. |
GensiaSicor Pharmaceuticals - Citizen Petition FDA-1998-P-0677 · 4 docket documents 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 | Other | 2009-10-07 | Open | — |
Citizen Petition from Veterinary Research Associates, Inc. FDA-1999-P-1293 · 3 docket documents 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 | 505(q) | 2009-10-07 | Denied | Veterinary Research Associates, Inc. |
Citizen Petition from Foley & Lardner LLP FDA-2006-P-0020 · 8 docket documents 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- | 505(q) | 2008-08-25 | Denied | Foley & Lardner LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1736
per ml
Lowest NADAC/Unit
$0.1736
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 25021060820PROPOFOL 200 MG/20 ML VIAL | $0.1736 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.