stavudine
These highlights do not include all the information needed to use STAVUDINE FOR ORAL SOLUTION safely and effectively. See full prescribing information for STAVUDINE FOR ORAL SOLUTION. STAVUDINE for oral solutionInitial U.S. Approval: 1994
Approved
Approval ID
17e597bc-d663-4d8e-a5d3-39816b628996
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2019
Manufacturers
FDA
Cipla Ltd.
DUNS: 650138746
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
stavudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53104-0111
Application NumberANDA078030
Product Classification
M
Marketing Category
C73584
G
Generic Name
stavudine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2019
FDA Product Classification
INGREDIENTS (6)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STAVUDINEActive
Quantity: 1 mg in 1 mL
Code: BO9LE4QFZF
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT