Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Fresenius Kabi Austria GmbH
Fresenius Kabi USA, LLC
303448575
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amikacin Sulfate
Product Details
NDC Product Code
63323-815Application Number
ANDA205604Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, INTRAMUSCULAREffective Date
May 31, 2023SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
AmikacinActive
Code: N6M33094FDClass: ACTIMQuantity: 250 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT