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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 211324

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NDA 211324 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 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 211324

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

Pharmacology for NDA: 211324

Mechanism of Action	Selective Estrogen Receptor Modulators

Medical Subject Heading (MeSH) Categories for 211324

Bone Density Conservation Agents
Estrogen Antagonists
Selective Estrogen Receptor Modulators

Suppliers and Packaging for NDA: 211324

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	211324	ANDA	A-S Medication Solutions	50090-6177	50090-6177-1	90 TABLET, COATED in 1 BOTTLE (50090-6177-1)
RALOXIFENE HYDROCHLORIDE	raloxifene hydrochloride	TABLET;ORAL	211324	ANDA	Cadila Pharmaceuticals Limited	71209-082	71209-082-01	30 TABLET, COATED in 1 BOTTLE (71209-082-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Aug 18, 2020	TE:	AB	RLD:	No

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