PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Generic: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Amneal Pharmaceuticals LLCManufacturer
ORALRoute
PROMETHAZINE HYDROCHLORIDEActive Substance
2011-02-08Original Approval
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is FDA application ANDA090575, sponsored by AMNEAL PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Top Reported Reactions
1
COLECTOMY
1 reports
2
INTESTINAL OBSTRUCTION
1 reports
3
NEUROPATHY PERIPHERAL
1 reports
4
PRODUCT USE IN UNAPPROVED INDICATION
1 reports
5
SOMNOLENCE
1 reports