Equetro

Treats acute manic or mixed episodes associated with bipolar I disorder Indicated. NDA 21710, held by Validus Pharms. Carbamazepine.

As of Nov 14, 2026, NDA 21710 (Equetro), held by Validus Pharms, was first approved by FDA on Dec 10, 2004, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 10, 2004
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1INDICATIONS AND USAGE EQUETRO is: A mood stabilizer indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder Indicated for the treatment of the pain associated with trigeminal neuralgia An anti-epileptic drug (AED) indicated for the treatment of partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures 1.1Acute Manic or Mixed Episodes associated with Bipolar I Disorder EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder. 1.2 Pain of Trigeminal Neuralgia EQUETRO is indicated in the treatment of the pain associated with trigeminal neuralgia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Sep 23, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 23, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 10, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Equetro100MG · capsule, extended release;oral	Carbamazepine	RxReference drug
Equetro200MG · capsule, extended release;oral	Carbamazepine	RxReference drug
Equetro300MG · capsule, extended release;oral	Carbamazepine	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Oct 14, 2022	Supplement 18Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 23, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 23, 2016	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 13, 2012	Supplement 9Labeling · Standard review	Approved	Label Letter
Jan 27, 2012	Supplement 13REMS	Approved	Letter
Oct 24, 2010	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 6Labeling	Approved	Label Letter
Dec 19, 2007	Supplement 5Labeling · Standard review	Approved	Letter
Dec 9, 2006	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 10, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21710
Drugs@FDA: Overview at FDA
Company: Validus Pharmaceuticals

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