Orange Book product · Brand (NDA)
CELLCEPT
MYCOPHENOLATE MOFETIL
At a glance
Jun 19, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 19, 1997
29 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
MYCOPHENOLATE MOFETIL
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 050723
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024MYHIBBINBrand (NDA)
NDA 216482 · AZURITY
- 1998CELLCEPTBrand (NDA)
NDA 050759 · ROCHE PALO
- 1995CELLCEPTBrand (NDA)
NDA 050722 · ROCHE PALO
- 2026MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 218566 · CONCORD BIOTECH LTD
- 2024MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 214079 · WUXI
- 2024MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 207022 · HETERO LABS LTD V
- 2024MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 208119 · HETERO LABS LTD V
- 2024MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 218227 · AUROBINDO PHARMA LTD
- 2024MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 217937 · AUROBINDO PHARMA
- 2024MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 217828 · AUROBINDO PHARMA LTD
- 2023MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 213955 · RISING
- 2023MYCOPHENOLATE MOFETILGeneric (ANDA)
ANDA 212634 · STRIDES PHARMA INTL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
