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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 206384


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NDA 206384 describes RALOXIFENE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma, 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.
Summary for 206384
Tradename:RALOXIFENE HYDROCHLORIDE
Applicant:Sciegen Pharms Inc
Ingredient:raloxifene hydrochloride
Patents:0
Pharmacology for NDA: 206384
Suppliers and Packaging for NDA: 206384
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 206384 ANDA Major Pharmaceuticals 0904-6902 0904-6902-04 30 BLISTER PACK in 1 CARTON (0904-6902-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
RALOXIFENE HYDROCHLORIDE raloxifene hydrochloride TABLET;ORAL 206384 ANDA Dr.Reddy?s Laboratories Inc 43598-505 43598-505-01 100 TABLET, FILM COATED in 1 BOTTLE (43598-505-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Oct 12, 2016TE:ABRLD:No

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