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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 207986


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NDA 207986 describes OTIPRIO, which is a drug marketed by Alk Abello and is included in one NDA. There are eight 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. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.
Summary for 207986
Tradename:OTIPRIO
Applicant:Alk Abello
Ingredient:ciprofloxacin
Patents:8
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 207986

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE, SUSPENSION;OTICStrength6% (60MG/ML)
Approval Date:Dec 10, 2015TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Nov 12, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS
Patent:⤷  Try a TrialPatent Expiration:Nov 27, 2038Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Apr 21, 2029Product Flag?YSubstance Flag?Delist Request?

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