FDA.reportPublic FDA data

Application 021252

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANASAMESALAMINESUPPOSITORY;RECTAL500MGNoNo
002CANASAMESALAMINESUPPOSITORY;RECTAL1GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58914-501CanasaMesalamineAllergan, Inc.NDACurrent
58914-501CanasaMesalamineAllergan, Inc.NDACurrent
58914-501CanasaMesalamineAllergan, Inc.NDACurrent
58914-501CanasaMesalamineAllerganNDACurrent
59762-0118MesalaminemesalamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0118MesalaminemesalamineGreenstone LLCNDACurrent
59762-0118MesalaminemesalamineGreenstone LLCNDACurrent
59762-0118MesalaminemesalamineGreenstone LLCNDACurrent
65084-474CanasaMesalamineMckesson Rxpak IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75943SUPPL 2023-10-25
75928SUPPL 2023-10-25
72644SUPPL2022-11-17
72628SUPPL2022-11-17
69205SUPPL2021-11-02
69198SUPPL2021-11-02
64864SUPPL2020-10-07
64798SUPPL2020-10-02
49183SUPPL2017-08-02
49141SUPPL2017-07-31
45228SUPPL2016-09-02
45203SUPPL2016-09-02
27223SUPPL2013-12-20
14752SUPPL2013-12-19
14751SUPPL2013-02-08
27222SUPPL2013-02-07
27221SUPPL2008-05-28
4779SUPPL2006-06-12
36468SUPPL2004-11-08
4777SUPPL2004-11-08
4778SUPPL2004-09-29
4776SUPPL2003-10-17
36467ORIG2003-04-08
21550ORIG2001-01-05
4775ORIG2001-01-05
51339ORIG1900-01-01
51338ORIG1900-01-01
51337ORIG1900-01-01