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McKesson
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Federal Trade Commission
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Generated: August 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208251

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NDA 208251 describes OTOVEL, which is a drug marketed by Laboratorios Salvat and is included in one NDA. It is available from one supplier. 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-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
Summary for 208251
Tradename:OTOVEL
Applicant:Laboratorios Salvat
Ingredient:ciprofloxacin hydrochloride; fluocinolone acetonide
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208251
Generic Entry Date for 208251*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
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.

Pharmacology for NDA: 208251
Ingredient-typeQuinolones
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 208251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OTOVEL ciprofloxacin hydrochloride; fluocinolone acetonide SOLUTION/DROPS;OTIC 208251 NDA Arbor Pharmaceuticals 24338-080 N 24338-080-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrengthEQ 0.3% BASE;0.025%
Approval Date:Apr 29, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 29, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:➤ Sign UpPatent Expiration:Mar 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE OTITIS MEDIA

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Accenture
Cipla
US Army
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Chubb
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Dow
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