FDA.reportPublic FDA data

Application 077633

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET;ORAL50MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET;ORAL100MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET;ORAL150MGNoNo
005LAMOTRIGINELAMOTRIGINETABLET;ORAL200MGNoNo
006LAMOTRIGINELAMOTRIGINETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7964LamotrigineLamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7975LamotrigineLamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8150LamotrigineLamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8267lamotriginelamotrigineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-7007LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
0904-7007LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
0904-7007LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
0904-7007LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
0904-7008LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
0904-7008LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
0904-7008LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
0904-7008LamotrigineLamotrigineMajor PharmaceuticalsANDACurrent
16714-194LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
16714-194LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
16714-195LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
16714-195LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
16714-196LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
16714-196LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
16714-197LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
16714-197LamotrigineLamotrigineNorthstar Rx LLC.ANDACurrent
50090-2814LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2825LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-4939LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-5567LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-5827LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-5828LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-5850LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
55154-2065LamotrigineLamotrigineCardinal HealthANDACurrent
55154-2065LamotrigineLamotrigineCardinal HealthANDACurrent
55154-2065LamotrigineLamotrigineCardinal Health 107, LLCANDACurrent
55154-2065LamotrigineLamotrigineCardinal HealthANDACurrent
55154-2330LamotrigineLamotrigineCardinal Health 107, LLCANDACurrent
55154-2330LamotrigineLamotrigineCardinal HealthANDACurrent
55154-2331LamotrigineLamotrigineCardinal Health 107, LLCANDACurrent
55154-2331LamotrigineLamotrigineCardinal HealthANDACurrent
55154-8137LamotrigineLamotrigineCardinal HealthANDACurrent
55154-8137LamotrigineLamotrigineCardinal HealthANDACurrent
55154-8142LamotrigineLamotrigineCardinal HealthANDACurrent
60687-693LamotrigineLamotrigineAmerican Health PackagingANDACurrent
60687-704LamotrigineLamotrigineAmerican Health PackagingANDACurrent
60760-474LamotrigineLamotrigineSt. Mary's Medical Park PharmacyANDACurrent
63739-179LamotrigineLamotrigineMcKesson Corporation dba SKY PackagingANDACurrent
63739-179LamotrigineLamotrigineMcKesson Corporation dba SKY PackagingANDACurrent
63739-670LamotrigineLamotrigineMcKesson CorporationANDACurrent
63739-670LamotrigineLamotrigineMcKesson Corporation dba SKY PackagingANDACurrent
63739-670LamotrigineLamotrigineMcKesson Corporation dba SKY PackagingANDACurrent
65084-179LamotrigineLamotrigineMcKesson Corporation dba RX PakANDACurrent
65084-179LamotrigineLamotrigineMcKesson Corporation dba RX PakANDACurrent
65841-682LamotrigineLamotrigineZydus Lifesciences LimitedANDACurrent
65841-682LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-682LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-682LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-683LamotrigineLamotrigineZydus Lifesciences LimitedANDACurrent
65841-683LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-683LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-683LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-684LamotrigineLamotrigineZydus Lifesciences LimitedANDACurrent
65841-684LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-684LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-684LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-685LamotrigineLamotrigineZydus Lifesciences LimitedANDACurrent
65841-685LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-685LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-685LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-686LamotrigineLamotrigineZydus Lifesciences LimitedANDACurrent
65841-686LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-686LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-686LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-687LamotrigineLamotrigineZydus Lifesciences LimitedANDACurrent
65841-687LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-687LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
65841-687LamotrigineLamotrigineCadila Healthcare LimitedANDACurrent
68084-318LamotrigineLamotrigineAmerican Health PackagingANDACurrent
68084-318LamotrigineLamotrigineAmerican Health PackagingANDACurrent
68084-318LamotrigineLamotrigineAmerican Health PackagingANDACurrent
68084-318LamotrigineLamotrigineAmerican Health PackagingANDACurrent
68084-318LamotrigineLamotrigineAmerican Health PackagingANDACurrent
68084-319LamotrigineLamotrigineAmerican Health PackagingANDACurrent
68084-319LamotrigineLamotrigineAmerican Health PackagingANDACurrent
68084-319LamotrigineLamotrigineAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22607ORIG2012-02-14