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Tobramycin

Tobramycin Ophthalmic Solution, USP0.3%–Sterile

Approved
Approval ID

73119111-c8a5-4415-83ad-2ccde56590b0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 20, 2018

Manufacturers
FDA

Aidarex Pharmaceuticals LLC

DUNS: 801503249

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 Code33261-519
Application NumberANDA064096
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tobramycin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 20, 2018
FDA Product Classification

INGREDIENTS (9)

TOBRAMYCINActive
Quantity: 3 mg in 1 mL
Code: VZ8RRZ51VK
Classification: ACTIB
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT

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Tobramycin - FDA Drug Approval Details