GABITRIL
Approved
Approval ID
175f2d9f-449b-4d95-a4b9-94f891f8e3ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TIAGABINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-832
Application NumberNDA020646
Product Classification
M
Marketing Category
C73594
G
Generic Name
TIAGABINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification
INGREDIENTS (14)
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TIAGABINE HYDROCHLORIDEActive
Quantity: 12 mg in 1 1
Code: DQH6T6D8OY
Classification: ACTIM
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT