FDA.reportPublic FDA data

Application 020610

Type
NDA
Sponsor
VALEANT PHARMS INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLAZALBALSALAZIDE DISODIUMCAPSULE;ORAL750MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDACurrent
65649-101Colazalbalsalazide disodiumSalix Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
68682-750balsalazide disodiumbalsalazide disodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-750balsalazide disodiumbalsalazide disodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-750balsalazide disodiumbalsalazide disodiumOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75939SUPPL 2023-10-25
75927SUPPL 2023-10-25
72643SUPPL2022-11-17
72629SUPPL2022-11-17
69204SUPPL2021-11-02
69199SUPPL2021-11-02
64861SUPPL2020-10-07
64797SUPPL2020-10-02
59160SUPPL2019-07-31
59175SUPPL2019-06-27
2872SUPPL2008-07-14
2871SUPPL2007-11-08
12844SUPPL2007-11-07
34955SUPPL2006-12-28
25323SUPPL2006-12-28
25322SUPPL2006-09-25
12843SUPPL2006-09-25
25321SUPPL2006-03-23
2870SUPPL2002-06-18
34954ORIG2000-07-18
25320ORIG2000-07-18
20764ORIG2000-07-18
53530SUPPL1900-01-01
53529SUPPL1900-01-01
53079ORIG1900-01-01
51778ORIG1900-01-01
51777ORIG1900-01-01
51775ORIG1900-01-01