Mycophenolate Mofetil
These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL FOR ORAL SUSPENSION. MYCOPHENOLATE MOFETIL, for oral suspension Initial U.S. Approval: 1995
Approved
Approval ID
27fd9381-8d82-4187-897f-98f41f94e90f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2022
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mycophenolate Mofetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1595
Application NumberANDA214871
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolate Mofetil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2022
FDA Product Classification
INGREDIENTS (9)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MYCOPHENOLATE MOFETILActive
Quantity: 200 mg in 1 mL
Code: 9242ECW6R0
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT