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FDA Approval

Raloxifene Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 18, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Raloxifene(60 mg in 1 1)

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
0440-5295
Application Number
ANDA090842
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 19, 2016
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 4F86W47BR6Class: ACTIBQuantity: 60 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: 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
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