Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Baxter Healthcare Corporation
005083209
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED
Baxter Healthcare Corporation
Baxter Healthcare Corporation
918603338
Products2
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
36000-242Application Number
ANDA206965Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
March 15, 2023TobramycinActive
Code: HJT0RXD7JKClass: ACTIMQuantity: 40 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 3.2 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Tobramycin
Product Details
NDC Product Code
36000-244Application Number
ANDA206965Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
March 15, 2023TobramycinActive
Code: HJT0RXD7JKClass: ACTIMQuantity: 40 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 3.2 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT