FDA.reportPublic FDA data

Application 015193

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESTINONPYRIDOSTIGMINE BROMIDESYRUP;ORAL60MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-3012Mestinonpyridostigmine bromideBausch Health Americas, Inc.NDACurrent
0187-3012Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3012Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3012Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3012Mestinonpyridostigmine bromideValeant Pharmaceuticals North America LLCNDACurrent
0187-3012Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3012Mestinonpyridostigmine bromideBausch Health Americas, Inc.NDACurrent
0187-3012Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
68682-307pyridostigmine bromidepyridostigmine bromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-307pyridostigmine bromidepyridostigmine bromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60718SUPPL2019-10-30
10854SUPPL2003-05-14
12076SUPPL2002-05-22