FDA.reportPublic FDA data

Application 075271

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CROMOLYN SODIUMCROMOLYN SODIUMSOLUTION;INHALATION10MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-6406Cromolyn SodiumCromolyn SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-6406Cromolyn SodiumCromolyn SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-6406Cromolyn SodiumCromolyn SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42969ORIG2001-12-26
18401ORIG2000-02-04
8591ORIG2000-01-18