Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
InvaGen Pharmaceuticals, Inc
165104469
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
InvaGen Pharmaceuticals, Inc
Exelan Pharmaceuticals, Inc.
InvaGen Pharmaceuticals, Inc
080334903
InvaGen Pharmaceuticals, Inc.
Exelan Pharmaceuticals, Inc.
InvaGen Pharmaceuticals, Inc
165104469
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
76282-256Application Number
ANDA090842Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 26, 2019CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
RaloxifeneActive
Code: 4F86W47BR6Class: ACTIBQuantity: 60 mg in 1 1
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT