FDA.reportPublic FDA data

Application 018240

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENORMINATENOLOLTABLET;ORAL50MGYesNo
002TENORMINATENOLOLTABLET;ORAL100MGYesYes
004TENORMINATENOLOLTABLET;ORAL25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52427-429TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-429TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-429TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-429TENORMINAtenololAlmatica Pharma Inc.NDACurrent
52427-429TENORMINAtenololAlmatica Pharma Inc.NDACurrent
52427-430TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-430TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-430TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-430TENORMINAtenololAlmatica Pharma Inc.NDACurrent
52427-430TENORMINAtenololAlmatica Pharma Inc.NDACurrent
52427-431TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-431TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-431TENORMINAtenololAlmatica Pharma LLCNDACurrent
52427-431TENORMINAtenololAlmatica Pharma Inc.NDACurrent
52427-431TENORMINAtenololAlmatica Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77161SUPPL 2023-12-27
77130SUPPL 2023-12-27
33463SUPPL2012-11-06
14957SUPPL2012-11-05
11187SUPPL2011-08-24
882SUPPL2011-08-18
14956SUPPL2008-05-05
881SUPPL2005-02-11
14955SUPPL2003-11-13
14954SUPPL2003-01-09
40788SUPPL2001-06-04
20117SUPPL2001-06-04