Dextroamphetamine
Dextroamphetamine Sulfate Oral Solution CII, 5 mg/5 mL Rx Only
Approved
Approval ID
7658071e-ee2c-4d23-94ce-1906959ec036
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2023
Manufacturers
FDA
Tris Pharma Inc
DUNS: 947472119
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextroamphetamine
PRODUCT DETAILS
NDC Product Code27808-085
Application NumberANDA203644
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 23, 2023
Generic NameDextroamphetamine
INGREDIENTS (7)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5 mg in 5 mL
Code: JJ768O327N
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SACCHARINInactive
Code: FST467XS7D
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT