Orange Book product · Brand (NDA)

ECOZA

ECONAZOLE NITRATE

Brand (NDA)NDA 205175RX RESILIA PHARMS

Oct 24, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 24, 2013
12 yr 10 mo ago
Today
Patent 10071054 expires
Listed drug product patent expiration.
Aug 08, 2031
in 5 yr 3 mo

Active ingredient

ECONAZOLE NITRATE

Strength

Dosage form

AEROSOL, FOAM

Route

TOPICAL

TE code

Not listed

Application

NDA 205175

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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