FDA Orange Book · active-ingredient family
Econazole nitrate
Econazole nitrate: 2 brands, 5 generics; first approved Dec 23, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
5
Listed patents
1
Next patent expiry
Aug 08, 2031
in 4 yr 11 mo
Brand (NDA) products
Originator applications
- RESILIA PHARMSNDA 2051752013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% AEROSOL, FOAM TOPICAL Rx — - SPECTAZOLERLDALVOGENNDA 0187511982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- ECONAZOLE NITRATEAUROBINDO PHARMA USAANDA 2103642018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB - ECONAZOLE NITRATEENCUBEANDA 0765742004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB - ECONAZOLE NITRATERSPADAGIS ISRAELANDA 0764792004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB - ECONAZOLE NITRATECHARTWELL RXANDA 0760752002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Discontinued — - ECONAZOLE NITRATESUN PHARMA CANADAANDA 0760052002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10071054 | in 4 yr 11 mo | Product |
Approval history
FDA approval span
First approval
44 yr 5 mo ago
Most recent approval
8 yr 7 mo ago
Approvals span 1982–2018 across 7 FDA applications.
Brand (NDA) 229%
Generic (ANDA) 571%
Econazole nitrate: 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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