FDA.reportPublic FDA data

Application 040466

Type
ANDA
Sponsor
APP PHARMS

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
51662-1348DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1348DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1348DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1348DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1374DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1374DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1374DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-664Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables and Vaccines, IncANDACurrent
52584-664Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideGeneral Injectables and Vaccines, IncANDACurrent
55154-9363Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
55154-9363Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
55154-9363Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal HealthANDACurrent
55154-9363Diphenhydramine Hydrochloridediphenhydramine hydrochlorideCardinal Health 107, LLCANDACurrent
63323-664DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-664DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-664DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-664DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-664DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-664DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7668ORIG2003-04-09