Synalar
SYNALAR (fluocinolone acetonide) Cream, 0.025%
Approved
Approval ID
5af2e4c1-082b-48a0-aae7-72d4a68cbb2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Medimetriks Pharmaceuticals, Inc.
DUNS: 019903816
Products 2
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 Code43538-901
Application NumberNDA012787
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 8, 2023
FDA Product Classification
fluocinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43538-900
Application NumberNDA012787
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (13)
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
fluocinolone acetonideActive
Quantity: 0.25 mg in 1 g
Code: 0CD5FD6S2M
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
polyoxyl 20 cetostearyl etherInactive
Code: YRC528SWUY
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT