FDA.reportPublic FDA data

Application 017422

Type
NDA
Sponsor
EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BICNUCARMUSTINEINJECTABLE;INJECTION100MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-261BiCNUCARMUSTINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDACurrent
23155-261BiCNUCARMUSTINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDACurrent
23155-261BiCNUCARMUSTINEHeritage Pharmaceuticals Inc.NDACurrent
23155-261BiCNUCARMUSTINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDACurrent
23155-649CARMUSTINECARMUSTINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
23155-649CARMUSTINECARMUSTINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
23155-649CARMUSTINECARMUSTINEHeritage Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
23155-790CARMUSTINECARMUSTINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70237SUPPL2022-02-23
47759SUPPL2017-03-29
47723SUPPL2017-03-27
33265SUPPL2016-06-17
581SUPPL2016-05-02
40742SUPPL2015-08-21
40741SUPPL2015-08-21
40740SUPPL2015-01-28
33264SUPPL2013-10-22
13134SUPPL2011-08-15
33263SUPPL2011-08-12
580SUPPL2011-03-16
33262SUPPL2011-03-14
13133SUPPL2007-08-22
33261SUPPL2007-08-21
579SUPPL2005-10-25
578SUPPL2003-03-10