Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
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
71610-524Application Number
ANDA090842Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 17, 2021MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
RaloxifeneActive
Code: 4F86W47BR6Class: ACTIBQuantity: 60 mg in 1 1
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT