Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GLAND PHARMA LIMITED
FOSUN PHARMA USA INC
918601238
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tobramycin
Product Details
NDC Product Code
72266-196Application Number
ANDA212628Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
September 16, 2021BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21JClass: IACT
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56Class: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TobramycinActive
Code: VZ8RRZ51VKClass: ACTIBQuantity: 3 mg in 1 mL