FDA.reportPublic FDA data

Application 087513

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEELIXIR;ORAL12.5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
69067-092DiphenDiphenhydramine HydrochlorideFoxland Pharmaceuticals, Inc.ANDACurrent
69067-092DiphenDiphenhydramine HydrochlorideFoxland Pharmaceuticals, Inc.ANDACurrent
71872-7242DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent
73480-150DI-PHENDIPHENHYDRAMINE HYDROCHLORIDETriVue Pharmaceuticals, Inc.ANDACurrent
73480-150DI-PHENDIPHENHYDRAMINE HYDROCHLORIDETriVue Pharmaceuticals, Inc.ANDACurrent