POLYETHYLENE GLYCOL 3350 | A076652 | LANNETT CO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Empire State Consumer Project FDA-2012-P-0566 · 5 docket documents Empire State Consumer Project, Inc. filed this citizen petition on June 3, 2012, requesting that the FDA Commissioner investigate the safety of polyethylene glycol 3350 and related PEG products for use in pediatric patients and take immediate action including recalling PEG 3350 laxatives, adding a b | Other | 2012-07-02 | Partially Denied | Empire State Consumer Project |
Nexgen Pharma, Inc. - Citizen Petition FDA-2009-P-0129 · 4 docket documents Nexgen Pharma, Inc. filed this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act to request that the FDA designate Nexgen Polyethylene Glycol 3350 Powder for Oral Solution as the reference-listed drug for polyethylene glycol 3350 oral solution products, as the previous RLD Mi | Other | 2009-03-09 | Denied | — |
Par Pharmaceuticals and Kali Laboratories, Inc. - Citizen Petition FDA-2008-P-0295 · 3 docket documents Par Pharmaceuticals and its subsidiary Kali Laboratories filed this petition requesting that FDA clarify and publicly disclose its policy regarding the continued marketing of Polyethylene Glycol 3350 Powder for Oral Solution under approved ANDAs for prescription use, alleging that FDA's April 2007 l | Other | 2008-05-13 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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