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Generated: October 23, 2017

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 four patents protecting this drug. Additional details are available on the OTIPRIO profile page.

The generic ingredient in OTIPRIO is ciprofloxacin. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.

Summary for NDA: 207986

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 207986

Ingredient-typeQuinolones

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, SUSPENSION;OTICStrength6% (60MG/ML)
Approval Date:Dec 10, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 10, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Apr 27, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OTIC INFECTION OR INFLAMMATION
Patent:► SubscribePatent 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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