CLOTRIMAZOLE
Approved
Approval ID
f003ee1a-a7f6-46b4-8ca7-60bc2ce732f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2010
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.
CLOTRIMAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-060
Application NumberANDA072640
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLOTRIMAZOLE
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 2, 2010
FDA Product Classification
INGREDIENTS (8)
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GU
Classification: IACT
OCTYLDODECYL STEARATEInactive
Code: K6F16QGO28
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT