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FDA Approval

URELLE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Meda Pharmaceuticals
DUNS: 051229602
Effective Date
January 13, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Methylene blue(10.8 mg in 1 1)
Phenyl salicylate(32.4 mg in 1 1)
Hyoscyamine(0.12 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

URELLE

Product Details

NDC Product Code
0037-6321
Route of Administration
ORAL
Effective Date
January 13, 2015
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: J50OIX95QVClass: ACTIBQuantity: 81 mg in 1 1
Code: T42P99266KClass: ACTIBQuantity: 10.8 mg in 1 1
Code: 28A37T47QOClass: ACTIBQuantity: 32.4 mg in 1 1
Code: 593YOG76RNClass: ACTIBQuantity: 40.8 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
Code: F2R8V82B84Class: ACTIBQuantity: 0.12 mg in 1 1
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