FDA.reportPublic FDA data

Application 076379

Type
ANDA
Sponsor
PADDOCK LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0150Midazolam HydrochlorideMidazolam HydrochloridePadagis US LLCANDACurrent
0574-0150Midazolam HydrochlorideMidazolam HydrochloridePaddock Laboratories, LLCANDACurrent
0574-0150Midazolam HydrochlorideMidazolam HydrochloridePaddock Laboratories, LLC.ANDACurrent
0574-0150Midazolam HydrochlorideMidazolam HydrochloridePadagis US LLCANDACurrent
0574-0150Midazolam HydrochlorideMidazolam HydrochloridePadagis US LLCANDACurrent
17856-0146Midazolam HydrochlorideMidazolam HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0146Midazolam HydrochlorideMidazolam HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
63629-2534Midazolam HydrochlorideMidazolam HydrochlorideBryant Ranch PrepackANDACurrent
63629-2534Midazolam HydrochlorideMidazolam HydrochlorideBryant Ranch PrepackANDACurrent
63629-2534Midazolam HydrochlorideMidazolam HydrochlorideBryant Ranch PrepackANDACurrent