Evekeo
Evekeo (amphetamine sulfate tablets, USP) CII
Approved
Approval ID
f469fb38-0380-4621-9db3-a4f429126156
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 24, 2023
Manufacturers
FDA
AZURITY PHARMACEUTICALS, INC.
DUNS: 117505635
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-026
Application NumberANDA200166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (5)
Amphetamine SulfateActive
Quantity: 10 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Amphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-022
Application NumberANDA200166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (4)
Amphetamine SulfateActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT