Details for New Drug Application (NDA): 021743
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NDA 021743 describes TARCEVA, which is a drug marketed by Osi Pharms and is included in one NDA. Additional details are available on the TARCEVA profile page.
The generic ingredient in TARCEVA is erlotinib hydrochloride. There is one drug master file entry for this compound. Ten 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 is one drug master file entry for this compound. Ten 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 |
Medical Subject Heading (MeSH) Categories for 021743
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| Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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