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Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL for oral suspension Initial U.S. Approval: 1995

Approved
Approval ID

36d4e16a-e965-4709-9f40-4a3941da127b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 30, 2023

Manufacturers
FDA

Teva Pharmaceuticals, Inc.

DUNS: 022629579

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 Code0480-1175
Application NumberANDA211272
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolate Mofetil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2021
FDA Product Classification

INGREDIENTS (12)

ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MYCOPHENOLATE MOFETILActive
Quantity: 200 mg in 1 mL
Code: 9242ECW6R0
Classification: ACTIB
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

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Mycophenolate Mofetil - FDA Drug Approval Details