Tobramycin

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 001627975

Effective Date

October 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tobramycin(300 mg in 4 mL)

Products1

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

NDC Product Code

0093-3750

Application Number

ANDA210915

Marketing Category

ANDA (C73584)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

October 27, 2023

Ingredients

Code: VZ8RRZ51VKClass: ACTIBQuantity: 300 mg in 4 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT