Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Lake Erie Medical DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
831276758
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole and Betamethasone Dipropionate
Product Details
NDC Product Code
55700-524Application Number
ANDA202894Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
June 6, 2017SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CETEARETH-30Inactive
Code: 1R9DCZ5FOXClass: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
ClotrimazoleActive
Code: G07GZ97H65Class: ACTIBQuantity: 10 mg in 1 g
BetamethasoneActive
Code: 826Y60901UClass: ACTIMQuantity: 0.5 mg in 1 g
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACT