STRATTERA
These highlights do not include all the information needed to use STRATTERA safely and effectively. See full prescribing information for STRATTERA. STRATTERA® (atomoxetine hydrochloride) capsule for oral use Initial U.S. Approval: 2002
Approved
Approval ID
f8f80fca-32b7-4fba-b0ab-e87530bc36b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATOMXETINE HYROCHLORIDE
PRODUCT DETAILS
NDC Product Code16590-337
Application NumberNDA021411
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 22, 2010
Generic NameATOMXETINE HYROCHLORIDE
INGREDIENTS (8)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ATOMOXETINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIB