FDA.reportPublic FDA data

Application 040498

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-124Diphenhydramine Hydrochloridediphenhydramine hydrochlorideMylan Institutional LLCANDACurrent
67457-124Diphenhydramine Hydrochloridediphenhydramine hydrochlorideMylan Institutional LLCANDACurrent