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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, Glenmark Pharms Ltd, and Teva Pharms Usa, and is included in six NDAs. It is available from twelve 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. Seventeen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.

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 Camber Pharmaceuticals Inc 31722-256 31722-256-01 100 TABLET in 1 BOTTLE (31722-256-01)
raloxifene hydrochloride
TABLET;ORAL 090842 ANDA Camber Pharmaceuticals Inc 31722-256 31722-256-10 1000 TABLET in 1 BOTTLE (31722-256-10)

Summary for product number 001

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

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