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Last Updated: May 11, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017970

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NDA 017970 describes NOLVADEX, which is a drug marketed by Astrazeneca and is included in one NDA. Additional details are available on the NOLVADEX profile page.

The generic ingredient in NOLVADEX is tamoxifen citrate. There are sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tamoxifen citrate profile page.
Summary for 017970
Tradename:NOLVADEX
Applicant:Astrazeneca
Ingredient:tamoxifen citrate
Patents:0
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 017970
Tradename Dosage Ingredient NDA Submissiondate
NOLVADEX TABLET;ORAL tamoxifen citrate 017970

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 21, 1994TE:RLD:Yes

Expired US Patents for NDA 017970

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-002 Mar 21, 1994   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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