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Details for New Drug Application (NDA): 076546

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NDA 076546 describes TRIMETHOBENZAMIDE HYDROCHLORIDE, which is a drug marketed by Hospira, Luitpold, Watson Labs, Smith And Nephew, Gavis Pharms, Sun Pharm Inds, and Solopak, and is included in ten NDAs. It is available from nine 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. Thirteen suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.

Summary for NDA: 076546

Tradename:
TRIMETHOBENZAMIDE HYDROCHLORIDE
Applicant:
Gavis Pharms
Ingredient:
trimethobenzamide hydrochloride
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076546

Physiological EffectEmesis Suppression

Suppliers and Packaging for NDA: 076546

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIMETHOBENZAMIDE HYDROCHLORIDE
trimethobenzamide hydrochloride
CAPSULE;ORAL 076546 ANDA GAVIS Pharmaceuticals, LLC 43386-660 43386-660-03 30 CAPSULE in 1 BOTTLE (43386-660-03)
TRIMETHOBENZAMIDE HYDROCHLORIDE
trimethobenzamide hydrochloride
CAPSULE;ORAL 076546 ANDA GAVIS Pharmaceuticals, LLC 43386-660 43386-660-24 100 CAPSULE in 1 BOTTLE (43386-660-24)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Aug 20, 2003TE:ABRLD:No


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