Clotrimazole
Clotrimazole Cream USP, 1%
Approved
Approval ID
77883cfd-f13c-40cb-88b2-8f777e1cdce9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2020
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole
PRODUCT DETAILS
NDC Product Code51672-1275
Application NumberANDA072640
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateJanuary 24, 2020
Generic NameClotrimazole
INGREDIENTS (7)
Sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
ClotrimazoleActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
cetyl esters waxInactive
Code: D072FFP9GU
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT