Stavudine
These highlights do not include all the information needed to use stavudine safely and effectively. See full prescribing information for stavudine capsules. Stavudine Capsules, USP Initial U.S. Approval: 1994
Approved
Approval ID
7501de1e-149d-405e-94f6-da4010952adf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2013
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 Code53808-0852
Application NumberANDA079069
Product Classification
M
Marketing Category
C73584
G
Generic Name
stavudine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2013
FDA Product Classification
INGREDIENTS (14)
STAVUDINEActive
Quantity: 20 mg in 1 1
Code: BO9LE4QFZF
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT