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.
IBU
Product Details
NDC Product Code
43353-273Application Number
ANDA075682Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 27, 2017silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 800 mg in 1 1
carnauba waxInactive
Code: R12CBM0EIZClass: IACT
polydextroseInactive
Code: VH2XOU12IEClass: IACT
Polyethylene GlycolsInactive
Code: 3WJQ0SDW1AClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT