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Last Updated: July 25, 2024

Details for New Drug Application (NDA): 020497

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NDA 020497 describes FARESTON, which is a drug marketed by Kyowa Kirin and is included in one NDA. It is available from one supplier. Additional details are available on the FARESTON profile page.

The generic ingredient in FARESTON is toremifene citrate. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.
Summary for 020497
Applicant:Kyowa Kirin
Ingredient:toremifene citrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 020497
Suppliers and Packaging for NDA: 020497
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FARESTON toremifene citrate TABLET;ORAL 020497 NDA Kyowa Kirin, Inc. 42747-327 42747-327-30 30 TABLET in 1 BOTTLE (42747-327-30)
FARESTON toremifene citrate TABLET;ORAL 020497 NDA Kyowa Kirin, Inc. 42747-327 42747-327-72 7 TABLET in 1 BLISTER PACK (42747-327-72)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 60MG BASE
Approval Date:May 29, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020497

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kyowa Kirin FARESTON toremifene citrate TABLET;ORAL 020497-001 May 29, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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