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Generated: April 30, 2017

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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 two suppliers. Additional details are available on the FARESTON profile page.

The generic ingredient in FARESTON is toremifene citrate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the toremifene citrate profile page.

Summary for NDA: 020497

Therapeutic Class:Antineoplastics
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
toremifene citrate
TABLET;ORAL 020497 NDA GTx, Inc. 11399-005 11399-005-01 100 TABLET in 1 BOTTLE (11399-005-01)
toremifene citrate
TABLET;ORAL 020497 NDA GTx, Inc. 11399-005 11399-005-07 7 TABLET in 1 BLISTER PACK (11399-005-07)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020497

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kyowa Kirin
toremifene citrate
TABLET;ORAL020497-001May 29, 19974,696,949► Subscribe
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