Acetic Acid
ACETIC ACID OTIC SOLUTION USP, 2%
Approved
Approval ID
eb6799c0-4ba3-4f30-908d-bd4eb27dc7a9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-4600
Application NumberANDA040166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetic Acid
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateAugust 15, 2017
FDA Product Classification
INGREDIENTS (6)
ACETIC ACIDActive
Quantity: 20 mg in 1 mL
Code: Q40Q9N063P
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLENE GLYCOL DIACETATEInactive
Code: 5Z492UNF9O
Classification: IACT
BENZETHONIUM CHLORIDEInactive
Code: PH41D05744
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT