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Hoffmann La Roche Company Profile
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Summary for Applicant: Hoffmann La Roche
| Patents: | 14 |
| Tradenames: | 12 |
| Ingredients: | 11 |
| NDAs: | 14 |
| Drug Master File Entries: (click here to view) | 40 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hoffmann La Roche | ROCEPHIN | ceftriaxone sodium | INJECTABLE;INJECTION | 050585-005 | Dec 21, 1984 | DISCN | No | ||||||||||||||||||||||
Hoffmann La Roche | XELODA | capecitabine | TABLET;ORAL | 020896-001 | Apr 30, 1998 | RX | No | Jun 10, 2017 | |||||||||||||||||||||
Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | 8,143,271 | Jun 21, 2026 | Y | Y | ||||||||||||||||||
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