FDA.reportPublic FDA data

Application 090170

Type
ANDA
Sponsor
UNICHEM LABS LTD

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
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-111LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-112LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-113LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-114LamotrigineLamotrigineUnichem Pharmaceuticals (USA), Inc.ANDACurrent
33261-648LamotrigineLamotrigineAidarex Pharmaceuticals LLCANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2129LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2130LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2130LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2130LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2131LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-2131LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
50090-3914LamotrigineLamotrigineA-S Medication SolutionsANDACurrent
53002-2512LamotrigineLamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
53002-2513LamotrigineLamotrigineRPK Pharmaceuticals, Inc.ANDACurrent
53808-0993LamotrigineLamotrigineState of Florida DOH Central PharmacyANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-626LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-683LamotrigineLamotrigineLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-1111LamotrigineLamotrigineClinical Solutions Wholesale, LLCANDACurrent
58118-1111LamotrigineLamotrigineClinical Solutions Wholesale, LLCANDACurrent
60760-050LamotrigineLamotrigineSt. Mary's Medical Park PharmacyANDACurrent
61919-534LAMOTRIGINELAMOTRIGINEDirectRXANDACurrent
61919-534LAMOTRIGINELAMOTRIGINEDirectRXANDACurrent
61919-777LAMOTRIGINELAMOTRIGINEDirect RXANDACurrent
61919-802LAMOTRIGINELAMOTRIGINEDIRECT RXANDACurrent
61919-802LAMOTRIGINELAMOTRIGINEDIRECT RXANDACurrent
63187-487LamotrigineLamotrigineProficient Rx LPANDACurrent
63187-487LamotrigineLamotrigineProficient Rx LPANDACurrent
63187-487LamotrigineLamotrigineProficient Rx LPANDACurrent
64725-0111LamotrigineLamotrigineTYA PharmaceuticalsANDACurrent
64725-0112LamotrigineLamotrigineTYA PharmaceuticalsANDACurrent
68071-2054LamotrigineLamotrigineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2729LamotrigineLamotrigineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2873LamotrigineLamotrigineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7168LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent
68788-7223LamotrigineLamotriginePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43235ORIG2011-12-16
18533ORIG2011-12-16