Details for New Drug Application (NDA): 211591
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NDA 211591 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.
Summary for 211591
| Tradename: | GEFITINIB |
| Applicant: | Qilu Pharm Hainan |
| Ingredient: | gefitinib |
| Patents: | 0 |
Pharmacology for NDA: 211591
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 211591
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEFITINIB | gefitinib | TABLET;ORAL | 211591 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-366 | 50742-366-30 | 30 TABLET, COATED in 1 BOTTLE (50742-366-30) |
| GEFITINIB | gefitinib | TABLET;ORAL | 211591 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0531 | 67184-0531-1 | 30 TABLET, COATED in 1 BOTTLE (67184-0531-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Feb 13, 2023 | TE: | AB | RLD: | No | ||||
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