FDA.reportPublic FDA data

Application 213949

Type
ANDA
Sponsor
YILING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL25MGNoNo
002LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL50MGNoNo
003LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL100MGNoNo
004LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL200MGNoNo
005LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL250MGNoNo
006LAMOTRIGINELAMOTRIGINETABLET, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-240lamotriginelamotrigine extended-releaseCamber Pharmaceuticals IncANDACurrent
31722-241lamotriginelamotrigine extended-releaseCamber Pharmaceuticals IncANDACurrent
31722-242lamotriginelamotrigine extended-releaseCamber Pharmaceuticals IncANDACurrent
31722-243lamotriginelamotrigine extended-releaseCamber Pharmaceuticals IncANDACurrent
31722-244lamotriginelamotrigine extended-releaseCamber Pharmaceuticals IncANDACurrent
31722-245lamotriginelamotrigine extended-releaseCamber Pharmaceuticals IncANDACurrent
69117-0044lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0044lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0045lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0045lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0046lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0046lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0047lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0047lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0048lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0048lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0049lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent
69117-0049lamotriginelamotrigine extended-releaseYiling Pharmaceutical, Inc.ANDACurrent