Neo-Synalar
NEO-SYNALAR [neomycin sulfate 0.5% (0.35% neomycin base), fluocinolone acetonide 0.025%] Cream
Approved
Approval ID
1141956e-8a4c-4f80-95d1-f15bdb57fdf6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Medimetriks Pharmaceuticals
DUNS: 019903816
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
neomycin sulfate and fluocinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43538-940
Application NumberANDA060700
Product Classification
M
Marketing Category
C73584
G
Generic Name
neomycin sulfate and fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (14)
neomycin sulfateActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIM
fluocinolone acetonideActive
Quantity: 0.25 mg in 1 g
Code: 0CD5FD6S2M
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171K
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
polyoxyl 20 cetostearyl etherInactive
Code: YRC528SWUY
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT