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Last Updated: October 6, 2022

Details for New Drug Application (NDA): 019726


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NDA 019726 describes ZOLADEX, which is a drug marketed by Tersera and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the ZOLADEX profile page.

The generic ingredient in ZOLADEX is goserelin acetate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the goserelin acetate profile page.
Summary for 019726
Tradename:ZOLADEX
Applicant:Tersera
Ingredient:goserelin acetate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 019726
Medical Subject Heading (MeSH) Categories for 019726
Suppliers and Packaging for NDA: 019726
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726 NDA A-S Medication Solutions 50090-3466 50090-3466-0 1 POUCH in 1 CARTON (50090-3466-0) > 1 IMPLANT in 1 POUCH
ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726 NDA TerSera Therapeutics LLC 70720-950 70720-950-36 1 POUCH in 1 CARTON (70720-950-36) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 3.6MG BASE
Approval Date:Dec 29, 1989TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Apr 13, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Apr 9, 2022Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 019726

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 See Plans and Pricing See Plans and Pricing
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 See Plans and Pricing See Plans and Pricing
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 See Plans and Pricing See Plans and Pricing
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 See Plans and Pricing See Plans and Pricing
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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