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Last Updated: September 23, 2021

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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 two suppliers. 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-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; fluocinolone acetonide profile page.
Summary for 208251
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208251
Generic Entry Date for 208251*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208251
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 1 POUCH in 1 CARTON (24338-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE (24338-080-25)
OTOVEL ciprofloxacin hydrochloride; fluocinolone acetonide SOLUTION/DROPS;OTIC 208251 NDA Wilshire Pharmaceuticals 52536-080 52536-080-14 1 POUCH in 1 CARTON (52536-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OTICStrengthEQ 0.3% BASE;0.025%
Approval Date:Apr 29, 2016TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Mar 24, 2030Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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