BENZOYL PEROXIDE | N214510 | MAYNE PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Valisure FDA-2024-P-1130 · 4 docket documents Valisure LLC filed this citizen petition on March 5, 2024, requesting that the FDA recall and suspend sales of benzoyl peroxide drug products used to treat acne because Valisure detected high levels of benzene, a known human carcinogen, in multiple product batches that increase substantially when st | Other | 2024-03-06 | Open | Valisure |
Douglas Barasatian - Citizen Petition FDA-2013-P-0228 · 3 docket documents Douglas Barasatian, a pharmacist, filed this petition on February 16, 2013, requesting that the FDA remove bleached white flour and all flour-bleaching chemicals including chlorine dioxide, benzoyl peroxide, potassium bromide, and chlorine gas from the GRAS list and prevent their sale in the United | Other | 2013-03-08 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9687465 | Nov 27, 2032 | — | — | Yes | — | |
| 9868103 | Aug 8, 2028 | — | — | Yes | — | |
| 10933046 | Feb 19, 2040 | — | — | Yes | — | |
| 10945987 | Feb 19, 2040 | — | — | — | — | |
| 11426378 | Aug 18, 2040 | — | — | — | — | |
| 11541026 | Feb 19, 2040 | — | — | — | — | |
| 11628155 | Dec 27, 2040 | — | — | — | — | |
| 11865100 | Feb 19, 2040 | — | — | — | — | |
| 11877997 | Feb 19, 2040 | — | — | — | — | |
| 11986456 | Feb 19, 2040 | — | — | — | — | |
| 12156946 | Feb 3, 2028 | — | — | Yes | — | — |
| 12257348 | May 23, 2041 | — | — | Yes | — | |
| 12295935 | Dec 27, 2040 | — | — | — | — | |
| 12350382 | Feb 3, 2028 | — | — | Yes | — | — |