Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Direct_Rx
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Direct_Rx
Direct_Rx
Direct_Rx
079254320
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
61919-941Application Number
ANDA075991Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 12, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 40 mg in 1 1