Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbinafine Hydrochloride
Product Details
NDC Product Code
43353-893Application Number
ANDA077714Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 15, 2017Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
TerbinafineActive
Code: 012C11ZU6GClass: ACTIMQuantity: 250 mg in 1 1
Microcrystalline CelluloseInactive
Code: OP1R32D61UClass: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2Class: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT