FDA.reportPublic FDA data

Application 204239

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINEZOLIDLINEZOLIDTABLET;ORAL600MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-749LinezolidLinezolidCamber Pharmaceuticals, Inc.ANDACurrent
31722-749LinezolidLinezolidCamber Pharmaceuticals, Inc.ANDACurrent
60687-309LinezolidLinezolidAmerican Health PackagingANDACurrent
60687-309LinezolidLinezolidAmerican Health PackagingANDACurrent
60687-309LinezolidLinezolidAmerican Health PackagingANDACurrent
60687-309LinezolidLinezolidAmerican Health PackagingANDACurrent
63629-8576LinezolidLinezolidBryant Ranch PrepackANDACurrent
70518-0527LinezolidLinezolidREMEDYREPACK INC.ANDACurrent
70518-0527LinezolidLinezolidREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10310ORIG2015-12-22
32525ORIG2015-04-13