Dyclonine hydrochloride
Dyclonine hydrochloride: 1 brand, 1 generic; first approved Nov 20, 2018; generic available.
Generic available: 1 ANDA application approved.
Brand (NDA) products
- DYCLONERLDASTRAZENECANDA 009925-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SOLUTION TOPICAL Discontinued - 0.5% SOLUTION TOPICAL Discontinued -
Generic (ANDA) products (1)
- DYCLOPRORSSEPTODONTANDA 20048020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5% SOLUTION TOPICAL Rx - 1% SOLUTION TOPICAL Rx -
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
All 2 applications were approved in 2018.
Dyclonine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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