Details for New Drug Application (NDA): 208251
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NDA 208251 describes OTOVEL, which is a drug marketed by Lab Salvat and is included in one NDA. There is one patent protecting this drug. Additional details are available on the OTOVEL profile page.
The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-four drug master file entries for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
The generic ingredient in OTOVEL is ciprofloxacin hydrochloride; fluocinolone acetonide. There are thirty-four drug master file entries for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
Summary for 208251
| Tradename: | OTOVEL |
| Applicant: | Lab Salvat |
| Ingredient: | ciprofloxacin hydrochloride; fluocinolone acetonide |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208251
Generic Entry Date for 208251*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OTIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | EQ 0.3% BASE;0.025% | ||||
| Approval Date: | Apr 29, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 24, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACUTE OTITIS MEDIA | ||||||||
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