
| Applicant | Tradename | Generic Name | NDA | Approval Date | Type | RLD | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|
| Shire | LIALDA | mesalamine | 022000 | Jan 16, 2007 | RX | Yes | Jan 16, 2010 | NEW PRODUCT |
| Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | 021676 | Mar 16, 2006 | RX | Yes | Jan 26, 2010 | TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YRS OF AGE, WHO HAVE NO KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY, AND HAVE ACHIEVED MENARCHE, IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL. |
| Novartis | FAMVIR | famciclovir | 020363 | Apr 26, 1996 | RX | No | Jan 28, 2010 | PEDIATRIC EXCLUSIVITY |
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