Manages spasticity. NDA 21447, held by Legacy. Tizanidine Hydrochloride.
As of Nov 14, 2026, NDA 21447 (Zanaflex), held by Legacy, was first approved by FDA on Aug 29, 2002, with 6 approved supplements and 0 published complete response letters.
Zanaflex is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with Zanaflex should be reserved for those daily activities and times when relief of spasticity is most important.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2002 | Original applicationNew dosage form · Standard review | Approved |
| ZanaflexEQ 2MG BASE · capsule;oral | Tizanidine Hydrochloride | RxReference drug |
| ZanaflexEQ 4MG BASE · capsule;oral | Tizanidine Hydrochloride | RxReference drug |
| ZanaflexEQ 6MG BASE · capsule;oral | Tizanidine Hydrochloride | RxReference drug |
| Nov 22, 2024 | Supplement 17Labeling · Standard review | Approved | |
| Dec 18, 2020 | Supplement 15Labeling · Standard review | Approved | |
| Aug 29, 2014 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Nov 7, 2013 | Supplement 11Labeling | Approved | |
| Mar 8, 2013 | Supplement 5Labeling · Standard review | Approved | |
| Jul 28, 2006 | Supplement 2Labeling · Standard review | Approved | |
| Aug 29, 2002 | Original applicationNew dosage form · Standard review | Approved |
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
