FDA.reportPublic FDA data

Application 078538

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DILTIAZEM HYDROCHLORIDEDILTIAZEM HYDROCHLORIDEINJECTABLE;INJECTION5MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6013Diltiazem HydrochlorideDiltiazem HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6013Diltiazem HydrochlorideDiltiazem HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6014Diltiazem HydrochlorideDiltiazem HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6014Diltiazem HydrochlorideDiltiazem HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6015Diltiazem HydrochlorideDiltiazem HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6015Diltiazem HydrochlorideDiltiazem HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-9217Diltiazem HydrochlorideDiltiazem HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-9217Diltiazem HydrochlorideDiltiazem HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-9218Diltiazem HydrochlorideDiltiazem HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-9218Diltiazem HydrochlorideDiltiazem HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-9219Diltiazem HydrochlorideDiltiazem HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-9219Diltiazem HydrochlorideDiltiazem HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
51662-1335DILTIAZEM HCIDILTIAZEM HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1335DILTIAZEM HCIDILTIAZEM HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1335DILTIAZEM HCIDILTIAZEM HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1335DILTIAZEM HCIDILTIAZEM HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
71872-7063Diltiazem HydrochlorideDiltiazem HydrochlorideMedical Purchasing Solutions, LLCANDACurrent