TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)
TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION 200mg/2mL (100mg/mL) 2mL VIAL
Approved
Approval ID
9bd0bfa0-c189-751c-e053-2a95a90a5f5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2024
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1430
Application NumberNDA017530
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 28, 2024
FDA Product Classification
INGREDIENTS (3)
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
TRIMETHOBENZAMIDE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: WDQ5P1SX7Q
Classification: ACTIB