FDA.reportPublic FDA data

Application 204412

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DELZICOLMESALAMINECAPSULE, DELAYED RELEASE;ORAL400MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5853DelzicolmesalamineAllergan, Inc.NDACurrent
0023-5853DelzicolmesalamineAllergan, Inc.NDACurrent
0023-5853DelzicolmesalamineAllergan, Inc.NDACurrent
0023-5853DelzicolmesalamineAllergan, Inc.NDACurrent
0023-5853DelzicolmesalamineAllergan, Inc.NDACurrent
0023-5853DelzicolmesalamineAllergan, Inc.NDACurrent
50090-3002DelzicolmesalamineA-S Medication SolutionsNDACurrent
50090-3002DelzicolmesalamineA-S Medication SolutionsNDACurrent
50090-3002DelzicolmesalamineA-S Medication SolutionsNDACurrent
59762-0117MESALAMINEMESALAMINEGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0117MESALAMINEMESALAMINEGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0117MESALAMINEMESALAMINEGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0117MESALAMINEMESALAMINEGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0117MESALAMINEMESALAMINEGreenstone LLCNDA AUTHORIZED GENERICCurrent
68151-5652DelzicolmesalamineCarilion Materials ManagementNDACurrent
70518-3239MESALAMINEMESALAMINEREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75945SUPPL 2023-10-25
75931SUPPL 2023-10-25
72648SUPPL2022-11-17
72624SUPPL2022-11-17
69196SUPPL2021-11-02
69190SUPPL2021-11-02
65828SUPPL2021-01-06
64860SUPPL2020-10-07
64803SUPPL2020-10-02
64108SUPPL2020-07-28
49140SUPPL2017-07-28
49124SUPPL2017-07-28
40389SUPPL2015-09-22
10341SUPPL2015-09-10
40388SUPPL2014-10-29
10340SUPPL2014-10-28
32557SUPPL2014-04-29
19557SUPPL2014-04-29
43463ORIG2013-06-10
32556ORIG2013-02-05
19556ORIG2013-02-05
51349ORIG1900-01-01
51348ORIG1900-01-01
51347ORIG1900-01-01
51346SUPPL1900-01-01
51345SUPPL1900-01-01
51344SUPPL1900-01-01