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FDA Orange Book · active-ingredient family

Ciprofloxacin hydrochloride; fluocinolone acetonide

Ciprofloxacin hydrochloride; fluocinolone acetonide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:OTOVEL · NDA 208251

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution/drops

ProductApplicantApplicationTEApproved
OTOVELRLDLAB SALVATNDA 208251—Apr 29, 2016

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8932610Mar 24, 2030in 3 yr 10 mo
ProductU-1578

Ciprofloxacin hydrochloride; fluocinolone acetonide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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