FDA.reportPublic FDA data

Application 021710

Type
NDA
Sponsor
VALIDUS PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30698-419EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-419EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-419EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-419EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-421EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-421EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-421EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-421EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-423EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-423EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-423EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent
30698-423EQUETROCarbamazepineValidus Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72390SUPPL2022-10-17
72389SUPPL2022-10-17
72356SUPPL2022-10-17
56344SUPPL2018-11-08
45421SUPPL2016-09-29
45420SUPPL2016-09-29
45372SUPPL2016-09-26
45371SUPPL2016-09-26
16236SUPPL2012-11-15
6026SUPPL2012-11-14
28430SUPPL2012-01-31
16235SUPPL2010-10-28
28427SUPPL2010-10-27
37496SUPPL2009-05-13
6025SUPPL2009-05-04
28426SUPPL2008-01-09
28425SUPPL2006-12-28
37495SUPPL2006-12-14
21783ORIG2006-07-05
37494ORIG2004-12-10
28424ORIG2004-12-10