Details for New Drug Application (NDA): 206995
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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
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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