FDA.reportPublic FDA data

Application 011265

Type
NDA
Sponsor
ANI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
256SUPPL2009-11-09
33036SUPPL2008-04-16
255SUPPL2008-04-09
40669SUPPL2007-07-06
254SUPPL2004-01-22