Diclofenac Sodium 1.5%
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See Full Prescribing Information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution. Initial U.S. Approval: 1988
Approved
Approval ID
c3f33952-44a8-71b2-e053-2a95a90abda2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
SOLA Pharmaceuticals
DUNS: 080121345
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac Sodium Topical
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70512-038
Application NumberANDA204132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium Topical
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (6)
DICLOFENAC SODIUMActive
Quantity: 16.05 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT