Zecuity

NDA 202278, held by Teva Branded Pharm. Sumatriptan Succinate.

As of Nov 13, 2026, NDA 202278 (Zecuity), held by Teva Branded Pharm, was first approved by FDA on Jan 17, 2013, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 17, 2013
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jan 17, 2013	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZecuityEQ 6.5MG BASE/4HR · system;iontophoresis	Sumatriptan Succinate	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Aug 24, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 7, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 16, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 21, 2014	Supplement 1Labeling · Standard review	Approved	Letter Label
Mar 21, 2014	Supplement 2Labeling · Standard review	Approved	Label Letter
Jan 17, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 17, 2013	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 202278
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters