FDA.reportPublic FDA data

Application 090696

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-600Midazolam hydrochlorideMidazolam hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-600Midazolam hydrochlorideMidazolam hydrochlorideHeritage PharmaceuticalsANDACurrent
23155-600Midazolam hydrochlorideMidazolam hydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
47781-588Midazolammidazolam hydrochlorideAlvogen Inc.ANDACurrent
47781-588Midazolammidazolam hydrochlorideAlvogen Inc.ANDACurrent
47781-588Midazolammidazolam hydrochlorideAlvogen Inc.ANDACurrent
68083-106Midazolam hydrochlorideMidazolam hydrochlorideGland Pharma LimitedANDACurrent
68083-106Midazolam hydrochlorideMidazolam hydrochlorideGland Pharma LimitedANDACurrent
68083-106Midazolam hydrochlorideMidazolam hydrochlorideGland Pharma LimitedANDACurrent
70860-600Midazolammidazolam hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-600Midazolammidazolam hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
72611-741midazolammidazolamAlmaject, Inc.ANDACurrent
72611-741midazolammidazolamAlmaject, Inc.ANDACurrent
72611-741midazolammidazolamAlmaject, Inc.ANDACurrent