FDA.reportPublic FDA data

Application 078027

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALMOTRIPTAN MALATEALMOTRIPTAN MALATETABLET;ORALEQ 6.25MG BASENoNo
002ALMOTRIPTAN MALATEALMOTRIPTAN MALATETABLET;ORALEQ 12.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5260Almotriptan MalateAlmotriptan MalateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5260Almotriptan MalateAlmotriptan MalateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5260Almotriptan MalateAlmotriptan MalateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5261Almotriptan MalateAlmotriptan MalateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5261Almotriptan MalateAlmotriptan MalateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5261Almotriptan MalateAlmotriptan MalateTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31322ORIG2015-07-10