FDA.reportPublic FDA data

Application 019651

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASACOLMESALAMINETABLET, DELAYED RELEASE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53808-0205AsacolmesalamineState of Florida DOH Central PharmacyNDACurrent
53808-0823ASACOLmesalamineState of Florida DOH Central PharmacyNDACurrent
55154-2305AsacolmesalamineCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64793SUPPL2020-10-02
64789SUPPL2020-10-02
49138SUPPL2017-07-28
49123SUPPL2017-07-28
11600SUPPL2015-05-29
17519SUPPL2015-05-28
11599SUPPL2013-10-22
1460SUPPL2013-10-21
11598SUPPL2010-05-28
1459SUPPL2010-05-28
17518SUPPL2009-11-12
33838SUPPL2009-10-06
1458SUPPL2007-04-20
20277SUPPL2003-06-18