Details for New Drug Application (NDA): 021743
✉ Email this page to a colleague
NDA 021743 describes TARCEVA, which is a drug marketed by Osi Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the TARCEVA profile page.
The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Summary for 021743
| Tradename: | TARCEVA |
| Applicant: | Osi Pharms |
| Ingredient: | erlotinib hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021743
| Mechanism of Action | Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for 021743
Suppliers and Packaging for NDA: 021743
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743 | NDA | Genentech, Inc. | 50242-062 | 50242-062-01 | 30 TABLET in 1 BOTTLE (50242-062-01) |
| TARCEVA | erlotinib hydrochloride | TABLET;ORAL | 021743 | NDA | Genentech, Inc. | 50242-063 | 50242-063-01 | 30 TABLET in 1 BOTTLE (50242-063-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 18, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 18, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 18, 2004 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021743
Complete Access Available with Subscription
