Details for New Drug Application (NDA): 019726

✉ Email this page to a colleague

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

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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Sign Up	⤷ Sign Up
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Sign Up	⤷ Sign Up
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Sign Up	⤷ Sign Up
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Sign Up	⤷ Sign Up
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726-001	Dec 29, 1989	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.