FDA.reportPublic FDA data

Application 075873

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDESYRUP;ORALEQ 2MG BASE/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3566Midazolam HydrochlorideMidazolam HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3566Midazolam HydrochlorideMidazolam HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3566Midazolam HydrochlorideMidazolam HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-3566Midazolam HydrochlorideMidazolam HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0904-7113Midazolam HydrochlorideMidazolam HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7114Midazolam HydrochlorideMidazolam HydrochlorideMajor PharmaceuticalsANDACurrent
17856-3566Midazolam HydrochlorideMidazolam HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-3566Midazolam HydrochlorideMidazolam HydrochlorideAtlantic Biologicals CorpsANDACurrent
17856-3566Midazolam HydrochlorideMidazolam HydrochlorideAtlantic Biologicals CorpsANDACurrent
60687-576Midazolam HydrochlorideMidazolam HydrochlorideAmerican Health PackagingANDACurrent
60687-576Midazolam HydrochlorideMidazolam HydrochlorideAmerican Health PackagingANDACurrent
68094-762Midazolam HydrochlorideMidazolam HydrochloridePrecision Dose Inc.ANDACurrent
68094-762Midazolam HydrochlorideMidazolam HydrochloridePrecision Dose Inc.ANDACurrent
68094-762Midazolam HydrochlorideMidazolam HydrochloridePrecision Dose Inc.ANDACurrent
68094-764Midazolam HydrochlorideMidazolam HydrochloridePrecision Dose Inc.ANDACurrent
68094-764Midazolam HydrochlorideMidazolam HydrochloridePrecision Dose Inc.ANDACurrent
68094-764Midazolam HydrochlorideMidazolam HydrochloridePrecision Dose Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8817ORIG2003-04-10