Details for New Drug Application (NDA): 205950

NDA 205950 describes TRIMETHOBENZAMIDE HYDROCHLORIDE, which is a drug marketed by Avet Lifesciences, Lupin, Sun Pharm Industries, Am Regent, Hospira, Smith And Nephew, Solopak, and Watson Labs, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the TRIMETHOBENZAMIDE HYDROCHLORIDE profile page.

The generic ingredient in TRIMETHOBENZAMIDE HYDROCHLORIDE is trimethobenzamide hydrochloride. There are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.

Summary for 205950

Tradename:	TRIMETHOBENZAMIDE HYDROCHLORIDE
Applicant:	Avet Lifesciences
Ingredient:	trimethobenzamide hydrochloride
Patents:	0

Pharmacology for NDA: 205950

Physiological Effect

Emesis Suppression

Suppliers and Packaging for NDA: 205950

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIMETHOBENZAMIDE HYDROCHLORIDE	trimethobenzamide hydrochloride	CAPSULE;ORAL	205950	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-180	23155-180-01	100 CAPSULE in 1 BOTTLE (23155-180-01)
TRIMETHOBENZAMIDE HYDROCHLORIDE	trimethobenzamide hydrochloride	CAPSULE;ORAL	205950	ANDA	Chartwell RX, LLC	62135-773	62135-773-30	30 CAPSULE in 1 PACKAGE (62135-773-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Nov 21, 2023	TE:	AB	RLD:	No

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