FDA.report

Application 075243

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/MLNoNo
002MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5MG BASE/MLNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9913MidazolamMidazolamHenry Schein, Inc.ANDACurrent
0404-9913MidazolamMidazolamHenry Schein, Inc.ANDACurrent
0641-6056MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6056MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6057MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6057MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6059MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6059MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6060MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6060MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6061MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6061MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6063MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6063MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6190MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6190MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6209MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6209MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6210MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6210MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6211MidazolamMidazolamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6211MidazolamMidazolamWest-Ward Pharmaceuticals Corp.ANDACurrent
50090-0683MidazolamMidazolamA-S Medication SolutionsANDACurrent
50090-0738MidazolamMidazolamA-S Medication SolutionsANDACurrent
52584-055MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-055MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-056MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-056MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-059MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-059MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-059MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-059MidazolamMidazolamGeneral Injectables and Vaccines, Inc.ANDACurrent
55154-2889MidazolamMidazolamCardinal HealthANDACurrent
55154-2889MidazolamMidazolamCardinal HealthANDACurrent
72572-430MidazolamMidazolamCivica, Inc.ANDACurrent
72572-430MidazolamMidazolamCivica, Inc.ANDACurrent
72572-432MidazolamMidazolamCivica, Inc.ANDACurrent
72572-432MidazolamMidazolamCivica, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
30813ORIG2004-06-09
8579ORIG2000-06-20