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Last Updated: November 22, 2024

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. Fourteen 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

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10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca NOLVADEX tamoxifen citrate TABLET;ORAL 017970-002 Mar 21, 1994 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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