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Details for New Drug Application (NDA): 017530

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NDA 017530 describes TIGAN, which is a drug marketed by Par Sterile Products and King Pharms 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. Thirteen suppliers are listed for this compound. Additional details are available on the trimethobenzamide hydrochloride profile page.

Summary for NDA: 017530

Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 017530

Physiological EffectEmesis Suppression

Suppliers and Packaging for NDA: 017530

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
trimethobenzamide hydrochloride
INJECTABLE;INJECTION 017530 NDA Rebel Distributors Corp 21695-853 21695-853-20 1 VIAL, MULTI-DOSE in 1 CARTON (21695-853-20) > 20 mL in 1 VIAL, MULTI-DOSE
trimethobenzamide hydrochloride
INJECTABLE;INJECTION 017530 NDA Par Pharmaceutical, Inc. 42023-118 42023-118-01 1 VIAL, MULTI-DOSE in 1 CARTON (42023-118-01) > 20 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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