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Regulatory Exclusivity: NEW PRODUCT
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Drugs with New Product Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | RX | Yes | Yes | Get Started for $10 | ||
| Medicis | LUZU | luliconazole | CREAM;TOPICAL | 204153-001 | Nov 14, 2013 | RX | Yes | Yes | Get Started for $10 | ||
| Scilex Pharms Inc | ZTLIDO | lidocaine | PATCH;TOPICAL | 207962-001 | Feb 28, 2018 | RX | Yes | Yes | Get Started for $10 | ||
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-001 | Oct 28, 2010 | AB | RX | Yes | Yes | Get Started for $10 | |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-002 | Oct 28, 2010 | AB | RX | Yes | No | Get Started for $10 | |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-003 | Dec 7, 2011 | AB | RX | Yes | No | Get Started for $10 | |
| Sunovion Pharms Inc | LATUDA | lurasidone hydrochloride | TABLET;ORAL | 200603-005 | Jul 12, 2013 | AB | RX | Yes | No | Get Started for $10 | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
