Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Amneal Pharmaceuticals, LLC
Amneal Pharmaceuticals LLC
963900878
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinolone Acetonide
Product Details
NDC Product Code
65162-703Application Number
ANDA201759Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
December 18, 2023Fluocinolone acetonideActive
Code: 0CD5FD6S2MClass: ACTIBQuantity: 0.11 mg in 118.28 mL
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
OLETH-2Inactive
Code: 7L6R1SQ6M0Class: IACT