ZERIT
ZERIT (stavudine) CapsulesZERIT (stavudine) for Oral Solution
Approved
Approval ID
8bb73c56-74cb-4602-b9a3-57bd1082b434
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 12, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 3
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 Code53808-0657
Application NumberNDA020412
Product Classification
M
Marketing Category
C73594
G
Generic Name
stavudine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (7)
STAVUDINEActive
Quantity: 30 mg in 1 1
Code: BO9LE4QFZF
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
stavudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0795
Application NumberNDA020412
Product Classification
M
Marketing Category
C73594
G
Generic Name
stavudine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (7)
STAVUDINEActive
Quantity: 40 mg in 1 1
Code: BO9LE4QFZF
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
stavudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0656
Application NumberNDA020412
Product Classification
M
Marketing Category
C73594
G
Generic Name
stavudine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2010
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STAVUDINEActive
Quantity: 20 mg in 1 1
Code: BO9LE4QFZF
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT