FDA.reportPublic FDA data

Application 020712

Type
NDA
Sponsor
SHIRE DEV LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBATROLCARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORAL200MGYesNo
002CARBATROLCARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORAL300MGYesYes
003CARBATROLCARBAMAZEPINECAPSULE, EXTENDED RELEASE;ORAL100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0407CarbamazepinecarbamazepineATLANTIC BIOLOGICALS CORP.NDA AUTHORIZED GENERICCurrent
17856-0407CarbamazepinecarbamazepineATLANTIC BIOLOGICALS CORP.NDA AUTHORIZED GENERICCurrent
54092-171CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-171CarbatrolcarbamazepineShire US Manufacturing Inc.NDACurrent
54092-171CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-171CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-171CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-172CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-172CarbatrolcarbamazepineShire US Manufacturing Inc.NDACurrent
54092-172CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-172CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-172CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-173CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-173CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-173CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
54092-173CarbatrolcarbamazepineShire US Manufacturing Inc.NDACurrent
54092-173CarbatrolcarbamazepineTakeda Pharmaceuticals America, Inc.NDACurrent
66993-407CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-407CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-407CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-408CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-408CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-408CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-409CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-409CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-409CarbamazepinecarbamazepinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
69189-0410CarbamazepinecarbamazepineAvera McKennan HospitalNDA AUTHORIZED GENERICCurrent
70518-0124CarbamazepinecarbamazepineREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2524CarbamazepinecarbamazepineREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73981SUPPL 2023-04-12
73978SUPPL 2023-04-12
73977SUPPL 2023-04-12
69465SUPPL2021-12-03
69451SUPPL2021-12-02
55350SUPPL2018-08-28
55335SUPPL2018-08-28
43672SUPPL2013-05-22
35207SUPPL2013-03-26
35206SUPPL2013-03-26
3179SUPPL2013-03-25
3178SUPPL2013-03-25
25612SUPPL2011-09-06
3177SUPPL2011-02-03
35205SUPPL2011-01-31
25611SUPPL2009-04-29
13276SUPPL2009-04-28
3176SUPPL2008-01-09
23978SUPPL2007-12-31
13275SUPPL2007-12-12
20871ORIG2007-04-17
3175SUPPL2006-07-13
13274SUPPL2006-07-03
3174SUPPL2006-01-30