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.
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
| Tradename: | OTOVEL |
| Applicant: | Laboratorios Salvat |
| Ingredient: | ciprofloxacin hydrochloride; fluocinolone acetonide |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208251
Generic Entry Date for 208251*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OTIC |
*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
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors |
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 AUTHORIZED GENERIC | Xspire Pharma, LLC | 42195-128 | 42195-128-14 | 1 POUCH in 1 CARTON (42195-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE |
| OTOVEL | ciprofloxacin hydrochloride; fluocinolone acetonide | SOLUTION/DROPS;OTIC | 208251 | NDA | WraSer LLC | 66992-128 | 66992-128-14 | 1 POUCH in 1 CARTON (66992-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | EQ 0.3% BASE;0.025% | ||||
| Approval Date: | Apr 29, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 8,932,610 | Patent Expiration: | Mar 24, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACUTE OTITIS MEDIA | ||||||||
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