FDA.reportPublic FDA data

Application 012342

Type
NDA
Sponsor
CONCORDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003PARNATETRANYLCYPROMINE SULFATETABLET;ORALEQ 10MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-5590Tranylcypromine Sulfatetranylcypromine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-5590Tranylcypromine Sulfatetranylcypromine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-5590Tranylcypromine Sulfatetranylcypromine sulfateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
59212-447PARNATEtranylcypromine sulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-447PARNATEtranylcypromine sulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-447PARNATEtranylcypromine sulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-447PARNATEtranylcypromine sulfateConcordia Pharmaceuticals Inc.NDACurrent
59212-447PARNATEtranylcypromine sulfateConcordia Pharmaceuticals Inc.NDACurrent
64980-183Tranylcypromine Sulfatetranylcypromine sulfateRising Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50975SUPPL2018-01-05
50974SUPPL2018-01-05
33081SUPPL2010-05-28
12003SUPPL2010-05-21
10801SUPPL2009-12-02
23094ORIG2009-11-20
12002SUPPL2007-08-07
33080SUPPL2007-08-03
44000ORIG2007-05-09
12001SUPPL2006-01-30
322SUPPL2006-01-30
10800SUPPL2005-01-13
321SUPPL2005-01-13
12000SUPPL2001-03-15
11999SUPPL2001-03-15
11998SUPPL2001-03-15
11997SUPPL2001-03-15
320SUPPL2001-03-15
319SUPPL2001-03-15
318SUPPL2001-03-15