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Generated: April 24, 2017

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Details for New Drug Application (NDA): 090842

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NDA 090842 describes RALOXIFENE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Watson Labs Inc, Invagen Pharms, Sciegen Pharms Inc, Glenmark Pharms Ltd, and Teva Pharms Usa, and is included in seven 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 fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.

Summary for NDA: 090842

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 090842

Suppliers and Packaging for NDA: 090842

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
raloxifene hydrochloride
TABLET;ORAL 090842 ANDA Liberty Pharmaceuticals, Inc. 0440-5295 0440-5295-01 100 TABLET, FILM COATED in 1 BOTTLE (0440-5295-01)
raloxifene hydrochloride
TABLET;ORAL 090842 ANDA Liberty Pharmaceuticals, Inc. 0440-5295 0440-5295-05 500 TABLET, FILM COATED in 1 BOTTLE (0440-5295-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Sep 24, 2014TE:ABRLD:No

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