Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Northwind Pharmaceuticals, LLC
036986393
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Northwind Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
Northwind Pharmaceuticals, LLC
036986393
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glimepiride
Product Details
NDC Product Code
51655-120Application Number
ANDA078181Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 20, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
GlimepirideActive
Code: 6KY687524KClass: ACTIBQuantity: 4 mg in 1 1