Application 022500

Type
NDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONIDINECLONIDINETABLET, EXTENDED RELEASE;ORALEQ 0.17MG BASENoNo
002CLONIDINECLONIDINETABLET, EXTENDED RELEASE;ORALEQ 0.26MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68134-603ClonidineClonidinePALMETTO PHARMACEUTICALS INC.NDA AUTHORIZED GENERICCurrent
71511-503Nexiclon XRClonidineAthena Bioscience, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
38767SUPPL2010-09-29
29785SUPPL2010-09-29
44761ORIG2010-05-12
42539ORIG2010-05-12
7463ORIG2009-12-11
17647ORIG2009-12-10