
| Applicant | Tradename | Generic Name | NDA | Approval Date | Type | RLD | Patent Number | Product | Substance | Delist Req. | Patent Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Kowa | LIVALO | pitavastatin calcium | 022363 | Aug 3, 2009 | RX | No | 5,856,336 | Y | Jan 5, 2016 | ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA | ||
| Meda Pharms | ACYCLOVIR AND HYDROCORTISONE | acyclovir; hydrocortisone | 022436 | Jul 31, 2009 | RX | Yes | RE39264 | Y | Feb 2, 2016 | NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER) | ||
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | 021759 | Nov 17, 2006 | RX | Yes | 5,716,988*PED | Y | Feb 7, 2016 |
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