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Last Updated: April 19, 2024

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 one supplier. 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. One supplier is 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:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019726

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 019726

Antineoplastic Agents, Hormonal

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	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:	RX	Dosage:	IMPLANT;IMPLANTATION			Strength	EQ 3.6MG BASE
Approval Date:	Dec 29, 1989	TE:		RLD:	Yes

Expired US Patents for NDA 019726

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Try a Trial	⤷ Try a Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Try a Trial	⤷ Try a Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Try a Trial	⤷ Try a Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Try a Trial	⤷ Try a Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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