Lovastatin

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

NuCare Pharmaceuticals, Inc.

DUNS Number

010632300

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

66267-561

Application Number

ANDA075991

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 11, 2021

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JGClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: 9LHU78OQFDClass: ACTIBQuantity: 40 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT