Synalar
SYNALAR (fluocinolone acetonide) Ointment, 0.025%
Approved
Approval ID
d2d155cf-a635-4ab7-87de-34e90b9a74cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Medimetriks Pharmaceuticals, Inc.
DUNS: 019903816
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluocinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43538-910
Application NumberNDA013960
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (2)
fluocinolone acetonideActive
Quantity: 0.25 mg in 1 g
Code: 0CD5FD6S2M
Classification: ACTIB
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT