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 is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.
The generic ingredient in OTIPRIO is ciprofloxacin. There is one drug master file entry 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 |
Medical Subject Heading (MeSH) Categories for 207986
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE, SUSPENSION;OTIC | Strength | 6% (60MG/ML) | ||||
| Approval Date: | Dec 10, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 12, 2037 | Product 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: | ⤷ Start Trial | Patent Expiration: | Nov 27, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 21, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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