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Tigan

Tigan 100 mg/mL Injection 2 mL Single Dose Vial

Approved
Approval ID

d86e48ca-7e98-4e9c-9b1e-f80fef1c7c2a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 27, 2022

Manufacturers
FDA

General Injectables & Vaccines, Inc

DUNS: 108250663

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trimethobenzamide Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52584-119
Application NumberNDA017530
Product Classification
M
Marketing Category
C73594
G
Generic Name
Trimethobenzamide Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 27, 2022
FDA Product Classification

INGREDIENTS (3)

Trimethobenzamide HydrochlorideActive
Quantity: 100 mg in 1 mL
Code: WDQ5P1SX7Q
Classification: ACTIB
SODIUM CITRATEInactive
Quantity: 0.5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT

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Tigan - FDA Drug Approval Details