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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Boehringer Ingelheim
Medtronic
AstraZeneca
Cerilliant
Dow
Teva
Covington
Julphar

Generated: October 17, 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:► SubscribePatent Expiration:Mar 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE OTITIS MEDIA


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Moodys
Covington
Baxter
Boehringer Ingelheim
Cipla
Daiichi Sankyo
Teva
Harvard Business School
Cerilliant

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