FDA.reportPublic FDA data

Application 070345

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLURAZEPAM HYDROCHLORIDEFLURAZEPAM HYDROCHLORIDECAPSULE;ORAL30MGNoYes
002FLURAZEPAM HYDROCHLORIDEFLURAZEPAM HYDROCHLORIDECAPSULE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4415Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4415Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4415Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4415Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4430Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4430Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4430Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4430Flurazepam Hydrochlorideflurazepam hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
55289-038Flurazepam Hydrochlorideflurazepam hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-038Flurazepam Hydrochlorideflurazepam hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-038Flurazepam Hydrochlorideflurazepam hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-038Flurazepam Hydrochlorideflurazepam hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent