VENLAFAXINE HYDROCHLORIDE
Approved
Approval ID
b4048138-3b43-4952-9c4d-f9278792f2b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 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.
VENLAFAXINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-644
Application NumberANDA078301
Product Classification
M
Marketing Category
C73584
G
Generic Name
VENLAFAXINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 9, 2011
FDA Product Classification
INGREDIENTS (8)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
VENLAFAXINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 7D7RX5A8MO
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT