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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Fish and Richardson
Johnson and Johnson

Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076570

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NDA 076570 describes TRIMETHOBENZAMIDE HYDROCHLORIDE, which is a drug marketed by Gavis Pharms, Sun Pharm Industries, Hospira, Luitpold, Smith And Nephew, Solopak, and Watson Labs, and is included in ten 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. Ten suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.
Summary for 076570
Applicant:Sun Pharm Industries
Ingredient:trimethobenzamide hydrochloride
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076570
Physiological EffectEmesis Suppression
Suppliers and Packaging for NDA: 076570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIMETHOBENZAMIDE HYDROCHLORIDE trimethobenzamide hydrochloride CAPSULE;ORAL 076570 ANDA Rebel Distributors Corp. 21695-448 E 21695-448-10
TRIMETHOBENZAMIDE HYDROCHLORIDE trimethobenzamide hydrochloride CAPSULE;ORAL 076570 ANDA Sun Pharmaceutical Industries, Inc. 53489-376 N 53489-376-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Aug 28, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Boehringer Ingelheim

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