Details for New Drug Application (NDA): 212827
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NDA 212827 describes GEFITINIB, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Natco, and Qilu Pharm Hainan, and is included in four NDAs. It is available from five suppliers. Additional details are available on the GEFITINIB profile page.
The generic ingredient in GEFITINIB is gefitinib. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gefitinib profile page.
The generic ingredient in GEFITINIB is gefitinib. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gefitinib profile page.
Pharmacology for NDA: 212827
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 212827
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEFITINIB | gefitinib | TABLET;ORAL | 212827 | ANDA | Natco Pharma USA LLC | 69339-168 | 69339-168-03 | 30 TABLET, FILM COATED in 1 BOTTLE (69339-168-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | May 31, 2023 | TE: | AB | RLD: | No | ||||
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