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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS | |||
| Actelion Pharms Ltd | OPSUMIT | macitentan | TABLET;ORAL | 204410-001 | Oct 18, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL MEDITERRANEAN FEVER | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |
