FDA.reportPublic FDA data

Application 078511

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/MLNoNo
002MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-764Midazolam hydrochlorideMidazolam hydrochlorideWockhardt LimitedANDACurrent
55648-765Midazolam hydrochlorideMidazolam hydrochlorideWockhardt LimitedANDACurrent
64679-764Midazolam hydrochlorideMidazolam hydrochlorideWockhardt USA LLC.ANDACurrent
64679-765Midazolam hydrochlorideMidazolam hydrochlorideWockhardt USA LLC.ANDACurrent