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Details for New Drug Application (NDA): 020578

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NDA 020578 describes ZOLADEX, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ZOLADEX profile page.

The generic ingredient in ZOLADEX is goserelin acetate. There are three 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 NDA: 020578

Tradename:
ZOLADEX
Applicant:
Astrazeneca
Ingredient:
goserelin acetate
Patents:3
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020578

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 AstraZeneca Pharmaceuticals LP 0310-0951 0310-0951-30 1 POUCH in 1 CARTON (0310-0951-30) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 10.8MG BASE
Approval Date:Jan 11, 1996TE:RLD:Yes
Patent:7,118,552Patent Expiration:Apr 13, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,220,247Patent Expiration:Apr 9, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,500,964Patent Expiration:Feb 26, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020578

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
ZOLADEX
goserelin acetate
IMPLANT;IMPLANTATION020578-001Jan 11, 19964,100,274► subscribe
Astrazeneca
ZOLADEX
goserelin acetate
IMPLANT;IMPLANTATION020578-001Jan 11, 19965,366,734► subscribe
Astrazeneca
ZOLADEX
goserelin acetate
IMPLANT;IMPLANTATION020578-001Jan 11, 19964,767,628► subscribe
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