Application 040420

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENYTOINPHENYTOINSUSPENSION;ORAL125MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0067PhenytoinPhenytoinAtlantic Biologicals CorpsANDACurrent
60432-131PhenytoinPhenytoinMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-131PhenytoinPhenytoinMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-131PhenytoinPhenytoinMorton Grove Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42626ORIG2006-04-20
7655ORIG2003-04-09