FDA.reportPublic FDA data

Application 209363

Type
NDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOLOSECSECNIDAZOLEGRANULE;ORAL2GM/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
27437-051SOLOSECsecnidazoleLupin Pharmaceuticals, Inc.NDACurrent
64811-401SolosecSECNIDAZOLERopack Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69986SUPPL2022-01-27
69985SUPPL2022-01-27
69982SUPPL2022-01-27
69981SUPPL2022-01-27
69703SUPPL2021-12-21
69615SUPPL2021-12-17
68017SUPPL2021-07-07
68005SUPPL2021-07-01
67825SUPPL2021-06-15
67818SUPPL2021-06-15
50053ORIG2017-10-13
49751ORIG2017-09-15
49750ORIG2017-09-15