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Details for New Drug Application (NDA): 200825

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NDA 200825 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 sixteen 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: 200825

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

Pharmacology for NDA: 200825

Suppliers and Packaging for NDA: 200825

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
raloxifene hydrochloride
TABLET;ORAL 200825 ANDA Actavis Pharma, Inc. 0591-2367 0591-2367-01 100 TABLET, FILM COATED in 1 BOTTLE (0591-2367-01)
raloxifene hydrochloride
TABLET;ORAL 200825 ANDA Actavis Pharma, Inc. 0591-2367 0591-2367-10 1000 TABLET, FILM COATED in 1 BOTTLE (0591-2367-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Jan 21, 2015TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.