FDA.reportPublic FDA data

Application 202810

Type
NDA
Sponsor
SUPERNUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXTELLAR XROXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL150MGYesNo
002OXTELLAR XROXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL300MGYesNo
003OXTELLAR XROXCARBAZEPINETABLET, EXTENDED RELEASE;ORAL600MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17772-121OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-121OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-121OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-121OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-122OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-122OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-122OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-122OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-123OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-123OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-123OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent
17772-123OXTELLAR XROXCARBAZEPINESupernus Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79416SUPPL 2024-08-16
79410SUPPL 2024-08-16
79409SUPPL 2024-08-16
75289SUPPL 2023-08-25
75023SUPPL 2023-08-09
57152SUPPL2019-01-09
56884SUPPL2018-12-20
32310SUPPL2015-12-08
19382SUPPL2015-12-08
24422ORIG2012-11-29
22898ORIG2012-11-29
32309ORIG2012-10-23
23497ORIG2012-10-22
19381ORIG2012-10-22
51533ORIG1900-01-01
51532ORIG1900-01-01
51531ORIG1900-01-01