Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Health Packaging
American Health Packaging
929561009
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
60687-266Application Number
ANDA090842Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 4, 2022HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
RaloxifeneActive
Code: 4F86W47BR6Class: ACTIBQuantity: 60 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT