FDA.reportPublic FDA data

Application 205723

Type
ANDA
Sponsor
MICRO LABS

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
42571-169DIPHENHYDRAMINEDiphenhydramine HydrochlorideMicro Labs LimitedANDACurrent
42571-169DIPHENHYDRAMINEDiphenhydramine HydrochlorideMicro Labs LimitedANDACurrent
42571-169DIPHENHYDRAMINEDiphenhydramine HydrochlorideMicro Labs LimitedANDACurrent
42571-337DIPHENHYDRAMINEDiphenhydramine HydrochlorideMicro Labs LimitedANDACurrent
42571-337DIPHENHYDRAMINEDiphenhydramine HydrochlorideMicro Labs LimitedANDACurrent
42571-337DIPHENHYDRAMINEDiphenhydramine HydrochlorideMicro Labs LimitedANDACurrent
70518-3332Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3332Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideREMEDYREPACK INC.ANDACurrent
71872-7180Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
72485-101Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideArmas Pharmaceuticals Inc.ANDACurrent
72485-101Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideArmas Pharmaceuticals Inc.ANDACurrent
72485-102Diphenhydramine HydrochlorideDiphenhydramine HydrochlorideArmas Pharmaceuticals Inc.ANDACurrent