FDA.reportPublic FDA data

Application 200888

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORAL25MG;EQ 200MG FREE ACID AND POTASSIUM SALTNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofenWalgreen CompanyANDACurrent
0363-0756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWalgreensANDACurrent
0363-0756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWalgreensANDACurrent
0363-0756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWalgreensANDACurrent
11673-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
11673-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
11673-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTARGET CorporationANDACurrent
36800-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)ANDACurrent
36800-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)ANDACurrent
36800-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)ANDACurrent
49035-858Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-858Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-858Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
50844-611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofenL.N.K. International, Inc.ANDACurrent
50844-611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofenL.N.K. International, Inc.ANDACurrent
50844-611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofenL.N.K. International, Inc.ANDACurrent
50844-611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofenL.N.K. International, Inc.ANDACurrent
50844-732Ibuprofen PMIbuprofen and Diphenhydramine HClLNK International, Inc.ANDACurrent
55910-856Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-856Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-856Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
64380-732IBUPROFEN AND DIPHENHYDRAMINE HCLIBUPROFEN AND DIPHENHYDRAMINE HCLStrides Pharma Science LimitedANDACurrent
64380-732IBUPROFEN AND DIPHENHYDRAMINE HCLIBUPROFEN AND DIPHENHYDRAMINE HCLStrides Shasun LimitedANDACurrent
69842-656Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS PharmacyANDACurrent
69842-656Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS PharmacyANDACurrent
69842-656Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS PharmacyANDACurrent