Application 011559

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BREVITAL SODIUMMETHOHEXITAL SODIUMINJECTABLE;INJECTION500MG/VIALYesYes
002BREVITAL SODIUMMETHOHEXITAL SODIUMINJECTABLE;INJECTION2.5GM/VIALYesYes
003BREVITAL SODIUMMETHOHEXITAL SODIUMINJECTABLE;INJECTION5GM/VIALNoNo
004BREVITAL SODIUMMETHOHEXITAL SODIUMINJECTABLE;INJECTION200MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42023-105Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-105Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-105Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-105Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-105Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-106Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-106Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-106Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent
42023-106Brevital Sodiummethohexital sodiumPar Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65150SUPPL2020-11-04
65082SUPPL2020-10-30
48216SUPPL2017-05-02
48188SUPPL2017-05-02
33048SUPPL2014-01-28
272SUPPL2014-01-24
10766SUPPL2008-06-12
271SUPPL2008-05-08
11941SUPPL2004-06-01
10765SUPPL2004-06-01
11940SUPPL2004-05-28
11939SUPPL2001-07-13