Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Clinical Solutions Wholesale, LLC
078710347
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Clinical Solutions Wholesale, LLC
Clinical Solutions Wholesale, LLC
Clinical Solutions Wholesale, LLC
078710347
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamotrigine
Product Details
NDC Product Code
58118-1111Application Number
ANDA090170Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 3, 2020MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LamotrigineActive
Code: U3H27498KSClass: ACTIBQuantity: 25 mg in 1 1
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT