PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | N008604 | ANI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen Health Research Group FDA-1976-N-0519 · 101 docket documents Public Citizen Health Research Group and the University of Maryland Sudden Infant Death Syndrome Institute filed this petition requesting that the FDA immediately ban all over-the-counter use of promethazine hydrochloride products including Phenergan DM and Phenergan VC, contraindicate prescription | Other | 2011-03-25 | Granted | Public Citizen Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.