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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207986

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NDA 207986 describes OTIPRIO, which is a drug marketed by Otonomy Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the OTIPRIO profile page.

The generic ingredient in OTIPRIO is ciprofloxacin. There are thirty-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.
Summary for 207986
Tradename:OTIPRIO
Applicant:Otonomy Inc
Ingredient:ciprofloxacin
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 207986
Medical Subject Heading (MeSH) Categories for 207986
Suppliers and Packaging for NDA: 207986
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986 NDA Otonomy, Inc. 69251-201 69251-201-01 1 VIAL, SINGLE-USE in 1 CARTON (69251-201-01) > 1 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, SUSPENSION;OTICStrength6% (60MG/ML)
Approval Date:Dec 10, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 2, 2021
Regulatory Exclusivity Use:TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS
Patent:  Start TrialPatent Expiration:Apr 27, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OTIC INFECTION OR INFLAMMATION
Patent:  Start TrialPatent Expiration:Apr 21, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PEDIATRIC PATIENTS WITH OTITIS MEDIA WITH EFFUSION UNDERGOING TYMPANOSTOMY TUBE PLACEMENT

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