TOBREX
Approved
Approval ID
b1d58360-96b4-4d23-82aa-3e4872dc0136
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2010
Manufacturers
FDA
STAT RX LLC USA
DUNS: 786036330
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 Code16590-225
Application NumberNDA050555
Product Classification
M
Marketing Category
C73594
G
Generic Name
TOBRAMYCIN
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 19, 2010
FDA Product Classification
INGREDIENTS (4)
TOBRAMYCINActive
Quantity: 3 mg in 1 g
Code: VZ8RRZ51VK
Classification: ACTIB
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
chlorobutanolInactive
Code: HM4YQM8WRC
Classification: IACT