Application 017473

Type
NDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORAPPIMOZIDETABLET;ORAL2MGYesNo
003ORAPPIMOZIDETABLET;ORAL1MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57844-151ORAPPimozideTeva Select BrandsNDACurrent
57844-198ORAPPimozideTeva Select BrandsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40744SUPPL2012-01-27
13152SUPPL2011-10-03
11000SUPPL2011-09-30
13151SUPPL2010-12-06
10999SUPPL2010-12-04
13150SUPPL2009-07-23
33280SUPPL2009-07-21
33279SUPPL2009-05-11
598SUPPL2009-05-06
597SUPPL2003-11-05
13149SUPPL2002-11-14