FDA.reportPublic FDA data

Application 204891

Type
ANDA
Sponsor
ORIT LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BISOPROLOL FUMARATEBISOPROLOL FUMARATETABLET;ORAL5MGNoNo
002BISOPROLOL FUMARATEBISOPROLOL FUMARATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
15955-373BISOPROLOL FUMARATEBISOPROLOL FUMARATEORIT LABORATORIES LLCANDACurrent
15955-373BISOPROLOL FUMARATEBISOPROLOL FUMARATEAlembic Labs LLCANDACurrent
15955-374BISOPROLOL FUMARATEBISOPROLOL FUMARATEORIT LABORATORIES LLCANDACurrent
15955-374BISOPROLOL FUMARATEBISOPROLOL FUMARATEAlembic Labs LLCANDACurrent
62332-603BISOPROLOL FUMARATEBISOPROLOL FUMARATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-603BISOPROLOL FUMARATEBISOPROLOL FUMARATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-604BISOPROLOL FUMARATEBISOPROLOL FUMARATEAlembic Pharmaceuticals Inc.ANDACurrent
62332-604BISOPROLOL FUMARATEBISOPROLOL FUMARATEAlembic Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46880ORIG2017-01-18