Acetic Acid
Acetic Acid Otic Solution, USP
Approved
Approval ID
f9b4d18b-25f3-604f-e053-6394a90a5531
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2984
Application NumberANDA040607
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetic Acid
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateApril 19, 2023
FDA Product Classification
INGREDIENTS (6)
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLENE GLYCOL DIACETATEInactive
Code: 5Z492UNF9O
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ACETIC ACIDActive
Quantity: 20.65 mg in 1 mL
Code: Q40Q9N063P
Classification: ACTIB