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Generated: November 16, 2018

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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, 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 nineteen 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. Twenty 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 0093-7290-10 1000 TABLET, FILM COATED in 1 BOTTLE (0093-7290-10)

Profile for product number 001

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

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