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FDA Orange Book · active-ingredient family

Econazole nitrate

Econazole nitrate is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ECOZA · NDA 205175

2

Brand (NDA)

5

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, foam, cream

ProductApplicantApplicationTEApproved
ECOZARLDRESILIA PHARMSNDA 205175—Oct 24, 2013
SPECTAZOLERLDALVOGENNDA 018751—Dec 23, 1982

Generic (ANDA) products (5)

ProductApplicantApplicationTEApproved
ECONAZOLE NITRATEAUROBINDO PHARMA USAANDA 210364ABApr 18, 2018
ECONAZOLE NITRATEENCUBEANDA 076574—Dec 17, 2004
ECONAZOLE NITRATEPADAGIS ISRAELANDA 076479ABJun 23, 2004
ECONAZOLE NITRATECHARTWELL RXANDA 076075—Nov 26, 2002
ECONAZOLE NITRATESUN PHARMA CANADAANDA 076005ABNov 26, 2002

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10071054Aug 08, 2031in 5 yr 3 mo
Product

Econazole nitrate — frequently asked questions

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

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