Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Denton Pharma, Inc. dba Northwind Pharmaceuticals
080355546
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lovastatin
Product Details
NDC Product Code
70934-755Application Number
ANDA075551Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 13, 2021LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 10 mg in 1 1