Diurex
Canadian Diurex Water Caplets
Approved
Approval ID
874aa629-1330-0c30-e053-2a95a90ac888
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Kobayashi Healthcare International, Inc.
DUNS: 156391729
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pamabrom
PRODUCT DETAILS
NDC Product Code52389-349
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic NamePamabrom
INGREDIENTS (15)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM GLUCONATEInactive
Code: 12H3K5QKN9
Classification: IACT
RIBOFLAVINInactive
Code: TLM2976OFR
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PAMABROMActive
Quantity: 50 mg in 1 1
Code: UA8U0KJM72
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CALCIUM SULFATE DIHYDRATEInactive
Code: 4846Q921YM
Classification: IACT