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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
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Medtronic
Argus Health
Harvard Business School
Cantor Fitzgerald
US Department of Justice
Mallinckrodt
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QuintilesIMS

Generated: June 25, 2017

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 NDA: 208251

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

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 24338-080-14 14 VIAL, SINGLE-DOSE in 1 CARTON (24338-080-14) > .25 mL in 1 VIAL, SINGLE-DOSE (24338-080-01)

Summary 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:8,932,610Patent Expiration:Mar 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE OTITIS MEDIA


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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Colorcon
Express Scripts
Boehringer Ingelheim
Covington
Moodys
Mallinckrodt
QuintilesIMS
Cipla
Cerilliant

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 verifification 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.

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