FDA.reportPublic FDA data

Application 009829

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MESTINONPYRIDOSTIGMINE BROMIDETABLET;ORAL60MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-3010Mestinonpyridostigmine bromideBausch Health Americas, Inc.NDACurrent
0187-3010Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3010Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3010Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3010Mestinonpyridostigmine bromideValeant Pharmaceuticals North America LLCNDACurrent
0187-3010Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
0187-3010Mestinonpyridostigmine bromideBausch Health Americas, Inc.NDACurrent
0187-3010Mestinonpyridostigmine bromideBausch Health US, LLCNDACurrent
50268-638Pyridostigmine BromidePyridostigmine BromideAvPAKNDA AUTHORIZED GENERICCurrent
68682-302Pyridostigmine BromidePyridostigmine BromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-302Pyridostigmine BromidePyridostigmine BromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-302Pyridostigmine BromidePyridostigmine BromideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10731SUPPL2003-04-03