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Last Updated: September 23, 2021

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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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
Summary for 208251
DrugPatentWatch® Estimated Generic Entry Opportunity 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.

Pharmacology for NDA: 208251
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 24338-080-14 1 POUCH in 1 CARTON (24338-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE (24338-080-25)
OTOVEL ciprofloxacin hydrochloride; fluocinolone acetonide SOLUTION/DROPS;OTIC 208251 NDA Wilshire Pharmaceuticals 52536-080 52536-080-14 1 POUCH in 1 CARTON (52536-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE

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
Patent:⤷  Try it FreePatent Expiration:Mar 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE OTITIS MEDIA

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.