You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215456

✉ Email this page to a colleague

« Back to Dashboard

NDA 215456 describes THIOTHIXENE, which is a drug marketed by Am Therap, Amneal, Chartwell Rx, Epic Pharma Llc, Novitium Pharma, Rising, Watson Labs, Alpharma Us Pharms, Paco, Teva, Teva Pharms, and Hikma, and is included in twenty-two NDAs. It is available from four suppliers. Additional details are available on the THIOTHIXENE profile page.

The generic ingredient in THIOTHIXENE is thiothixene hydrochloride. There are six drug master file entries for this compound. Additional details are available on the thiothixene hydrochloride profile page.

Summary for 215456

Tradename:	THIOTHIXENE
Applicant:	Amneal
Ingredient:	thiothixene
Patents:	0

Pharmacology for NDA: 215456

Medical Subject Heading (MeSH) Categories for 215456

Antipsychotic Agents
Dopamine Antagonists

Suppliers and Packaging for NDA: 215456

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIOTHIXENE	thiothixene	CAPSULE;ORAL	215456	ANDA	Amneal Pharmaceuticals NY LLC	60219-1673	60219-1673-1	100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1673-1)
THIOTHIXENE	thiothixene	CAPSULE;ORAL	215456	ANDA	Amneal Pharmaceuticals NY LLC	60219-1673	60219-1673-7	1000 CAPSULE in 1 BOTTLE, PLASTIC (60219-1673-7)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1MG
Approval Date:	Feb 28, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2MG
Approval Date:	Feb 28, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Feb 28, 2022	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.