Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
A-S Medication Solutions
A-S Medication Solutions
830016429
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Raloxifene hydrochloride
Product Details
NDC Product Code
50090-6177Application Number
ANDA211324Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 17, 2022HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
RaloxifeneActive
Code: 4F86W47BR6Class: ACTIBQuantity: 60 mg in 1 1
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT