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Details for New Drug Application (NDA): 206995

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

The generic ingredient in IRESSA is gefitinib. There are nine 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 NDA: 206995

Tradename:
IRESSA
Applicant:
Astrazeneca Pharms
Ingredient:
gefitinib
Patents:1
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 206995

Mechanism of ActionProtein 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)
IRESSA
gefitinib
TABLET;ORAL 206995 NDA AstraZeneca Pharmaceuticals LP 0310-0482 0310-0482-93 30 TABLET, COATED in 1 BOTTLE (0310-0482-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jul 13, 2015TE:RLD:Yes
Patent:5,770,599Patent Expiration:May 5, 2017Product Flag?YSubstance Flag?YDelist Request?
Patented Use: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
Regulatory Exclusivity Expiration:Jul 13, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jul 13, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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