Tobramycin

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Medsource Pharmaceuticals

DUNS Number

833685915

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

NDC Product Code

45865-427

Application Number

ANDA062535

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

July 27, 2018

Ingredients

Code: VZ8RRZ51VKClass: ACTIBQuantity: 3 mg in 1 mL

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

SODIUM SULFATEInactive

Code: 0YPR65R21JClass: IACT

TYLOXAPOLInactive

Code: Y27PUL9H56Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT