EVOXAC
Approved
Approval ID
bf6bebde-81ef-4a49-bd8b-2b7444f7adbf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 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.
CEVIMELINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-859
Application NumberNDA020989
Product Classification
M
Marketing Category
C73594
G
Generic Name
CEVIMELINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2011
FDA Product Classification
INGREDIENTS (4)
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT