Details for New Drug Application (NDA): 206995

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NDA 206995 describes IRESSA, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. Additional details are available on the IRESSA profile page.

The generic ingredient in IRESSA is gefitinib. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.

Summary for 206995

Tradename:	IRESSA
Applicant:	Astrazeneca
Ingredient:	gefitinib
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 206995

Mechanism of Action	Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 206995

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IRESSA	gefitinib	TABLET;ORAL	206995	NDA	AstraZeneca Pharmaceuticals LP	0310-0482	0310-0482-30	30 TABLET, COATED in 1 BOTTLE (0310-0482-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jul 13, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 13, 2022
Regulatory Exclusivity Use:	FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST

Expired US Patents for NDA 206995

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	IRESSA	gefitinib	TABLET;ORAL	206995-001	Jul 13, 2015	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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