FDA.reportPublic FDA data

Application 071293

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECAPSULE;ORAL100MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-0326Amantadine HydrochlorideAmantadine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-2048Amantadine HydrochlorideAmantadine HydrochlorideSandoz IncANDACurrent
0781-2320Amantadine HydrochlorideAmantadine HydrochlorideSandoz Inc.ANDACurrent
0832-2012Amantadine HydrochlorideAmantadine HydrochlorideUpsher-Smith Laboratories, Inc.ANDACurrent
33261-773Amantadine HydrochlorideAmantadine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
43353-947Amantadine HydrochlorideAmantadine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0020Amantadine HydrochlorideAmantadine HydrochlorideA-S Medication SolutionsANDACurrent
51079-247Amantadine HydrochlorideAmantadine HydrochlorideMylan Institutional Inc.ANDACurrent
68084-611Amantadine HydrochlorideAmantadine HydrochlorideAmerican Health PackagingANDACurrent
68151-2991Amantadine HydrochlorideAmantadine HydrochlorideCarilion Materials ManagementANDACurrent