FDA.reportPublic FDA data

Application 011665

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESTINONPYRIDOSTIGMINE BROMIDETABLET, EXTENDED RELEASE;ORAL180MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-3013Mestinonpyridostigmine bromideBausch Health Americas, Inc.NDACurrent
0187-3013Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3013Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3013Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3013Mestinonpyridostigmine bromideValeant Pharmaceuticals North America LLCNDACurrent
0187-3013Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3013Mestinonpyridostigmine bromideBausch Health Americas, Inc.NDACurrent
0187-3013Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
68682-301pyridostigmine bromidepyridostigmine bromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-301pyridostigmine bromidepyridostigmine bromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-301pyridostigmine bromidepyridostigmine bromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10771SUPPL2005-06-21