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Generated: December 17, 2017

DrugPatentWatch Database Preview

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 Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms Inc, Teva Pharms Usa, and Watson Labs Inc, and is included in seven NDAs. It is available from eighteen suppliers. Additional details are available on the RALOXIFENE HYDROCHLORIDE profile page.

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

Summary for 204310

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 204310

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 KAISER FOUNDATION HOSPITALS 0179-0212 0179-0212-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0212-70)
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 204310 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-253 43353-253-60 90 TABLET, FILM COATED in 1 BOTTLE (43353-253-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Aug 28, 2015TE:ABRLD:No


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