FDA.reportPublic FDA data

Application 074553

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIMETIDINE HYDROCHLORIDECIMETIDINE HYDROCHLORIDESOLUTION;ORALEQ 300MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0649CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0649CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0649CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0649CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0649CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0649CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-1298CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-1298CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-1298CimetidineCimetidine HydrochloridePharmaceutical Associates, Inc.ANDACurrent