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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 204310

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NDA 204310 describes RALOXIFENE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms Inc, Teva Pharms Usa, and Watson Labs Inc, and is included in eight NDAs. It is available from seventeen suppliers. Additional details are available on the RALOXIFENE HYDROCHLORIDE profile page.

The generic ingredient in RALOXIFENE HYDROCHLORIDE is raloxifene hydrochloride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.

Summary for 204310

Tradename:	RALOXIFENE HYDROCHLORIDE
Applicant:	Aurobindo Pharma
Ingredient:	raloxifene hydrochloride
Patents:	0

Pharmacology for NDA: 204310

Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for 204310

Bone Density Conservation Agents
Estrogen Antagonists
Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 204310

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	204310	ANDA	NorthStar Rx LLC	16714-213	16714-213-01	30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01)
RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	204310	ANDA	NorthStar Rx LLC	16714-213	16714-213-02	100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Aug 28, 2015	TE:	AB	RLD:	No

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