Amphetamine Sulfate
AMPHETAMINE SULFATE TABLETS, USP, CII
Approved
Approval ID
91add2e3-8359-47dc-b79f-197d36b02819
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Wilshire Pharmaceuticals
DUNS: 078657245
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 Code52536-059
Application NumberANDA200166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (5)
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
amphetamine sulfateActive
Quantity: 10 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Amphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52536-057
Application NumberANDA200166
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (4)
amphetamine sulfateActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT