FDA.reportPublic FDA data

Application 040320

Type
ANDA
Sponsor
KING PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAPAZOLEMETHIMAZOLETABLET;ORAL5MGNoNo
002TAPAZOLEMETHIMAZOLETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60793-104TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent
60793-104TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent
60793-104TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent
60793-104TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent
60793-105TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent
60793-105TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent
60793-105TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent
60793-105TAPAZOLEmethimazolePfizer Laboratories Div Pfizer IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17769SUPPL2012-07-25
7624ORIG2000-03-31