FDA.reportPublic FDA data

Application 077783

Type
ANDA
Sponsor
CIPLA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2466LAMOTRIGINELamotrigineA-S Medication SolutionsANDACurrent
50090-3171LAMOTRIGINELamotrigineA-S Medication SolutionsANDACurrent
50090-3171LAMOTRIGINELamotrigineA-S Medication SolutionsANDACurrent
50090-3278LAMOTRIGINELamotrigineA-S Medication SolutionsANDACurrent
50436-0149LAMOTRIGINELamotrigineUnit Dose ServicesANDACurrent
53002-1512LAMOTRIGINELamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1512LAMOTRIGINELamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1513LAMOTRIGINELamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1513LAMOTRIGINELamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
58118-2148LAMOTRIGINELamotrigineClinical Solutions Wholesale, LLCANDACurrent
58118-2148LAMOTRIGINELamotrigineClinical Solutions Wholesale, LLCANDACurrent
58118-2148LAMOTRIGINELamotrigineClinical Solutions Wholesale, LLCANDACurrent
60760-549LAMOTRIGINELamotrigineSt. Mary's Medical Park PharmacyANDACurrent
63187-744LAMOTRIGINELamotrigineProficient Rx LPANDACurrent
63187-744LAMOTRIGINELamotrigineProficient Rx LPANDACurrent
68788-6822LAMOTRIGINELamotriginePreferred Pharmaceuticals, IncANDACurrent
68788-6822LAMOTRIGINELamotriginePreferred Pharmaceuticals, IncANDACurrent
68788-7178LAMOTRIGINELamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7178LAMOTRIGINELamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7278LAMOTRIGINELamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7278LAMOTRIGINELamotriginePreferred Pharmaceuticals Inc.ANDACurrent
69097-148LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-148LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-148LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-148LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-149LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-149LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-149LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-149LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-151LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-151LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-151LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-151LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-152LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-152LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-152LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
69097-152LAMOTRIGINELamotrigineCipla USA Inc.ANDACurrent
70518-0001LAMOTRIGINELamotrigineREMEDYREPACK INC.ANDACurrent
70518-0001LAMOTRIGINELamotrigineREMEDYREPACK INC.ANDACurrent
70518-1480LAMOTRIGINELamotrigineREMEDYREPACK INC.ANDACurrent
70518-1480LAMOTRIGINELamotrigineREMEDYREPACK INC.ANDACurrent
70518-1602LAMOTRIGINELamotrigineREMEDYREPACK INC.ANDACurrent
70518-1602LAMOTRIGINELamotrigineREMEDYREPACK INC.ANDACurrent
71335-0010LAMOTRIGINELamotrigineBryant Ranch PrepackANDACurrent
71335-0044LAMOTRIGINELamotrigineBryant Ranch PrepackANDACurrent
71335-0044LAMOTRIGINELamotrigineBryant Ranch PrepackANDACurrent
71335-0057LAMOTRIGINELamotrigineBryant Ranch PrepackANDACurrent
71335-0276LAMOTRIGINELamotrigineBryant Ranch PrepackANDACurrent
71335-0276LAMOTRIGINELamotrigineBryant Ranch PrepackANDACurrent
76519-1150LAMOTRIGINELAMOTRIGINEH. J. Harkins Company Inc.ANDACurrent
76519-1151LAMOTRIGINELAMOTRIGINEH. J. Harkins Company Inc.ANDACurrent
76519-1165LAMOTRIGINELAMOTRIGINEH. J. Harkins Company Inc.ANDACurrent