Orange Book product · Generic (ANDA)
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
At a glance
Mar 31, 2017
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 31, 2017
9 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Strength
500MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 203859
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MYCOPHENOLATE MOFETIL HYDROCHLORIDE
- 1998CELLCEPTBrand (NDA)
NDA 050758 · ROCHE PALO
- 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 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.
