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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-085
Application NumberANDA203644
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2023
FDA Product Classification
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