FDA.reportPublic FDA data

Application 090850

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9914MIDAZOLAMmidazoalmHenry Schein, Inc.ANDACurrent
0404-9914MIDAZOLAMmidazoalmHenry Schein, Inc.ANDACurrent
23155-601Midazolam hydrochlorideMidazolam hydrochlorideHeritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals IncANDACurrent
23155-601Midazolam hydrochlorideMidazolam hydrochlorideHeritage PharmaceuticalsANDACurrent
47781-589Midazolammidazolam hydrochlorideAlvogen Inc.ANDACurrent
47781-589Midazolammidazolam hydrochlorideAlvogen Inc.ANDACurrent
47781-589Midazolammidazolam hydrochlorideAlvogen Inc.ANDACurrent
50090-3312Midazolammidazolam hydrochlorideA-S Medication SolutionsANDACurrent
50090-3435Midazolammidazolam hydrochlorideA-S Medication SolutionsANDACurrent
52584-589MIDAZOLAMmidazolam hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-589MIDAZOLAMmidazolam hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-589MIDAZOLAMmidazolam hydrochlorideGeneral Injectables & Vaccines, Inc.ANDACurrent
52584-749MIDAZOLAMmidazoalmGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-749MIDAZOLAMmidazoalmGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-749MIDAZOLAMmidazoalmGeneral Injectables and Vaccines, Inc.ANDACurrent
68083-108Midazolam HydrochlorideMidazolam HydrochlorideGland Pharma LimitedANDACurrent
68083-108Midazolam HydrochlorideMidazolam HydrochlorideGland Pharma LimitedANDACurrent
68083-108Midazolam HydrochlorideMidazolam HydrochlorideGland Pharma LimitedANDACurrent
70860-601Midazolammidazolam hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-601Midazolammidazolam hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
72611-749midazolammidazolamAlmaject, Inc.ANDACurrent
72611-749midazolammidazolamAlmaject, Inc.ANDACurrent
72611-749midazolammidazolamAlmaject, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22716ORIG2013-01-22