FDA.reportPublic FDA data

Application 021642

Type
NDA
Sponsor
ENDO PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NASCOBALCYANOCOBALAMINSPRAY, METERED;NASAL0.5MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49884-270NascobalcyanocobalaminPar Pharmaceutical, Inc.NDACurrent
49884-270NascobalcyanocobalaminPar Pharmaceutical, Inc.NDACurrent
49884-270NascobalcyanocobalaminPar Pharmaceutical, Inc.NDACurrent
49884-270NascobalcyanocobalaminPar Pharmaceutical, Inc.NDACurrent
49884-270NascobalcyanocobalaminPar Pharmaceutical, Inc.NDACurrent
49884-270NascobalcyanocobalaminPar Pharmaceutical , IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56829SUPPL2018-12-20
56756SUPPL2018-12-17
48859SUPPL2017-06-29
15915SUPPL2014-06-10
37388SUPPL2014-02-07
28301SUPPL2014-02-07
28300SUPPL2006-09-20
37387SUPPL2006-09-18
42247ORIG2006-06-16
28299ORIG2005-02-03
15914ORIG2005-02-03