FDA.reportPublic FDA data

Application 017398

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REGONOLPYRIDOSTIGMINE BROMIDEINJECTABLE;INJECTION5MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3040RegonolPyridostigmine BromideSandoz IncNDACurrent
0781-3040RegonolPyridostigmine BromideSandoz IncNDACurrent
0781-3040RegonolPyridostigmine BromideSandoz IncNDACurrent
0781-3040RegonolPyridostigmine BromideSandoz IncNDACurrent
0781-3040RegonolPyridostigmine BromideSandoz IncNDACurrent
0781-3040RegonolPyridostigmine BromideSandoz IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66994SUPPL2021-04-06
13130SUPPL2004-09-29
10982SUPPL2004-09-29
13129SUPPL2003-10-22