Last Updated: November 8, 2026

Details for New Drug Application (NDA): 204491

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NDA 204491 describes RALOXIFENE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms, Teva Pharms Usa, and Watson Labs Inc, and is included in eight NDAs. It is available from sixteen suppliers. Additional details are available on the RALOXIFENE HYDROCHLORIDE profile page.

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

Summary for 204491

Tradename:	RALOXIFENE HYDROCHLORIDE
Applicant:	Glenmark Pharms Ltd
Ingredient:	raloxifene hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 204491

Bone Density Conservation Agents
Estrogen Antagonists
Selective Estrogen Receptor Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Mar 22, 2016	TE:	AB	RLD:	No

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