Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ferndale Laboratories
Medimetriks Pharmaceuticals
005320536
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Neo-Synalar
Product Details
NDC Product Code
43538-940Application Number
ANDA060700Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
January 10, 2023NeomycinActive
Code: 057Y626693Class: ACTIMQuantity: 3.5 mg in 1 g
Fluocinolone acetonideActive
Code: 0CD5FD6S2MClass: ACTIBQuantity: 0.25 mg in 1 g
cetyl alcoholInactive
Code: 936JST6JCNClass: IACT
butylated hydroxytolueneInactive
Code: 1P9D0Z171KClass: IACT
citric acid monohydrateInactive
Code: 2968PHW8QPClass: IACT
edetate disodiumInactive
Code: 7FLD91C86KClass: IACT
propylparabenInactive
Code: Z8IX2SC1OHClass: IACT
methylparabenInactive
Code: A2I8C7HI9TClass: IACT
polyoxyl 20 cetostearyl etherInactive
Code: YRC528SWUYClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
mineral oilInactive
Code: T5L8T28FGPClass: IACT
stearyl alcoholInactive
Code: 2KR89I4H1YClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
white waxInactive
Code: 7G1J5DA97FClass: IACT