Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc.
946499746
Products2
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
0641-6166Application Number
ANDA063315Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
April 7, 2023SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
AmikacinActive
Code: N6M33094FDClass: ACTIMQuantity: 250 mg in 1 mL
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Amikacin Sulfate
Product Details
NDC Product Code
0641-6167Application Number
ANDA063315Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
April 7, 2023AmikacinActive
Code: N6M33094FDClass: ACTIMQuantity: 250 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCFClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT