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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 200825

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NDA 200825 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 200825

Tradename:	RALOXIFENE HYDROCHLORIDE
Applicant:	Watson Labs Inc
Ingredient:	raloxifene hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 200825

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:	Jan 21, 2015	TE:	AB	RLD:	No

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