FDA.reportPublic FDA data

Application 080738

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECAPSULE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53808-0238Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
67046-127Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEContract Pharmacy Services-PAANDACurrent