Details for New Drug Application (NDA): 020578

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NDA 020578 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 020578

Tradename:	ZOLADEX
Applicant:	Tersera
Ingredient:	goserelin acetate
Patents:	0

Pharmacology for NDA: 020578

Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 020578

Antineoplastic Agents, Hormonal

Suppliers and Packaging for NDA: 020578

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578	NDA	TerSera Therapeutics LLC	70720-951	70720-951-30	1 POUCH in 1 CARTON (70720-951-30) / 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 10.8MG BASE
Approval Date:	Jan 11, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020578

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996	⤷ Start Trial	⤷ Start Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996	⤷ Start Trial	⤷ Start Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996	⤷ Start Trial	⤷ Start Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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