FDA.reportPublic FDA data

Application 206623

Type
ANDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDECAPSULE;ORAL3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-128BUDESONIDE (ENTERIC COATED)BudesonideGolden State Medical Supply, Inc.ANDACurrent
51407-128BUDESONIDE (ENTERIC COATED)BudesonideGolden State Medical Supply, Inc.ANDACurrent
51862-580BUDESONIDE (ENTERIC COATED)BudesonideMayne Pharma Inc.ANDACurrent
51862-580BUDESONIDE (ENTERIC COATED)BudesonideMayne Pharma Inc.ANDACurrent
51862-582BUDESONIDE (ENTERIC COATED)BudesonideMayne Pharma Inc.ANDACurrent
51862-582BUDESONIDE (ENTERIC COATED)BudesonideMayne Pharma Inc.ANDACurrent
51862-582BUDESONIDE (ENTERIC COATED)BudesonideMayne Pharma Inc.ANDACurrent
51862-582BUDESONIDE (ENTERIC COATED)BudesonideMayne Pharma Inc.ANDACurrent
55700-590BUDESONIDE (ENTERIC COATED)BudesonideLake Erie Medical DBA Quality Care Products LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10588ORIG2016-04-11