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Last Updated: June 22, 2021

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Details for New Drug Application (NDA): 017531

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NDA 017531 describes TIGAN, which is a drug marketed by King Pharms Llc and Par Sterile Products and is included in two NDAs. It is available from five suppliers. Additional details are available on the TIGAN profile page.

The generic ingredient in TIGAN 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 017531
Applicant:King Pharms Llc
Ingredient:trimethobenzamide hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 017531
Physiological EffectEmesis Suppression
Suppliers and Packaging for NDA: 017531
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIGAN trimethobenzamide hydrochloride CAPSULE;ORAL 017531 NDA Pfizer Laboratories Div Pfizer Inc 61570-079 61570-079-01 100 CAPSULE in 1 BOTTLE (61570-079-01)
TIGAN trimethobenzamide hydrochloride CAPSULE;ORAL 017531 NDA REMEDYREPACK INC. 70518-1225 70518-1225-0 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-1225-0)

Profile for product number 006

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Dec 13, 2001TE:ABRLD:Yes

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