Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Lyne Laboratories, Inc.
Rising Pharmaceuticals, Inc.
053510459
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinolone Acetonide Oil
Product Details
NDC Product Code
64980-329Application Number
ANDA203378Marketing Category
ANDA (C73584)Route of Administration
AURICULAR (OTIC)Effective Date
October 25, 2018Fluocinolone acetonideActive
Code: 0CD5FD6S2MClass: ACTIBQuantity: 0.11 mg in 1 mL
PEANUT OILInactive
Code: 5TL50QU0W4Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
OLETH-2Inactive
Code: 7L6R1SQ6M0Class: IACT