Orange Book product · Brand (NDA)
CELLCEPT
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
At a glance
Aug 12, 1998
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 12, 1998
28 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Strength
500MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050758
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.
- 2023MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 214283 · BPI LABS
- 2022MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 216390 · ONESOURCE SPECIALTY
- 2021MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 211374 · AMNEAL
- 2021MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 212130 · MEITHEAL
- 2017MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 204473 · ZYDUS PHARMS
- 2017MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203859 · MYLAN LABS LTD
- 2017MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 204043 · RISING
- 2016MYCOPHENOLATE MOFETIL HYDROCHLORIDEGeneric (ANDA)
ANDA 203575 · PH HEALTH
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.
