Details for New Drug Application (NDA): 219265
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NDA 219265 describes LOMUSTINE, which is a drug marketed by Carnegie and is included in one NDA. It is available from one supplier. Additional details are available on the LOMUSTINE profile page.
The generic ingredient in LOMUSTINE is lomustine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lomustine profile page.
The generic ingredient in LOMUSTINE is lomustine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lomustine profile page.
Pharmacology for NDA: 219265
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 219265
Suppliers and Packaging for NDA: 219265
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOMUSTINE | lomustine | CAPSULE;ORAL | 219265 | ANDA | Carnegie Pharmaceuticals LLC | 80005-114 | 80005-114-02 | 5 CAPSULE in 1 BOTTLE (80005-114-02) |
| LOMUSTINE | lomustine | CAPSULE;ORAL | 219265 | ANDA | Carnegie Pharmaceuticals LLC | 80005-115 | 80005-115-02 | 5 CAPSULE in 1 BOTTLE (80005-115-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 27, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Oct 27, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Oct 27, 2025 | TE: | AB | RLD: | No | ||||
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