Stavudine
Approved
Approval ID
752d2c13-5ca5-40b3-b066-55a9b6b1287a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0594
Application NumberANDA079069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Stavudine
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2010
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STAVUDINEActive
Quantity: 40 mg in 1 1
Code: BO9LE4QFZF
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT