Details for New Drug Application (NDA): 210750
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NDA 210750 describes AFATINIB DIMALEATE, which is a drug marketed by Apotex and Hetero Labs Ltd V and is included in two NDAs. It is available from one supplier. Additional details are available on the AFATINIB DIMALEATE profile page.
The generic ingredient in AFATINIB DIMALEATE is afatinib dimaleate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the afatinib dimaleate profile page.
The generic ingredient in AFATINIB DIMALEATE is afatinib dimaleate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the afatinib dimaleate profile page.
Summary for 210750
| Tradename: | AFATINIB DIMALEATE |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | afatinib dimaleate |
| Patents: | 0 |
Pharmacology for NDA: 210750
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 210750
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AFATINIB DIMALEATE | afatinib dimaleate | TABLET;ORAL | 210750 | ANDA | Camber Pharmaceuticals, Inc. | 31722-781 | 31722-781-30 | 1 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| AFATINIB DIMALEATE | afatinib dimaleate | TABLET;ORAL | 210750 | ANDA | Camber Pharmaceuticals, Inc. | 31722-782 | 31722-782-30 | 1 BOTTLE in 1 CARTON (31722-782-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jul 14, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Jul 14, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Jul 14, 2026 | TE: | AB | RLD: | No | ||||
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