Lorzone

Manufacturing Establishments1

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

Labeler

Lake Erie Medical DBA Quality Care Products LLC

DUNS Number

831276758

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

NDC Product Code

55700-517

Application Number

ANDA040861

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 17, 2017

Ingredients

DOCUSATE SODIUMInactive

Code: F05Q2T2JA0Class: IACT

Code: H0DE420U8GClass: ACTIBQuantity: 375 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT