TOBRAMYCIN
Tobramycin for Injection, USP Rx only
Approved
Approval ID
c37c251f-92e9-40f0-8b0c-00d42875d776
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TOBRAMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-470
Application NumberANDA217519
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOBRAMYCIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 26, 2022
FDA Product Classification
INGREDIENTS (3)
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
TOBRAMYCIN SULFATEActive
Quantity: 1.2 g in 30 mL
Code: HJT0RXD7JK
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT