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Last Updated: May 11, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078193

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NDA 078193 describes RALOXIFENE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, 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 fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.
Summary for 078193
Tradename:RALOXIFENE HYDROCHLORIDE
Applicant:Teva Pharms Usa
Ingredient:raloxifene hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078193
Suppliers and Packaging for NDA: 078193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 078193 ANDA Teva Pharmaceuticals USA, Inc. 0093-7290 0093-7290-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-7290-01)
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 078193 ANDA Teva Pharmaceuticals USA, Inc. 0093-7290 0093-7290-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7290-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Mar 4, 2014TE:ABRLD:No

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