LOPREEZA

Manufacturing Establishments1

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

Labeler

Amneal Pharmaceuticals NY LLC

DUNS Number

123797875

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

NDC Product Code

69238-1610

Application Number

NDA020907

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 25, 2018

Ingredients

Code: 9S44LIC7OJClass: ACTIBQuantity: 0.5 mg in 1 1

Code: 4TI98Z838EClass: ACTIBQuantity: 1 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

COPOVIDONE K25-31Inactive

Code: D9C330MD8BClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT