GENTAMICIN SULFATE
Approved
Approval ID
e2eed774-9a41-4a03-b8c0-e785fabf3228
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GENTAMICIN SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-107
Application NumberANDA062531
Product Classification
M
Marketing Category
C73584
G
Generic Name
GENTAMICIN SULFATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 17, 2011
FDA Product Classification
INGREDIENTS (10)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 1 mg in 1 g
Code: 8X7386QRLV
Classification: ACTIB
POLYSORBATE 40Inactive
Code: STI11B5A2X
Classification: IACT
PROPYLENE GLYCOL MONOSTEARATEInactive
Code: F76354LMGR
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT