Orange Book product · Generic (ANDA)
MYCOPHENOLATE SODIUM
MYCOPHENOLATE SODIUM
At a glance
Feb 10, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 10, 2021
5 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
MYCOPHENOLATE SODIUM
Strength
EQ 180MG BASE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 214376
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MYCOPHENOLATE SODIUM
- 2004MYFORTICBrand (NDA)
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ANDA 216637 · FOSUN WANBANG
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ANDA 218603 · AUROBINDO PHARMA LTD
- 2023MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 217031 · BIOCON PHARMA
- 2021MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 214630 · BIOCON PHARMA
- 2021MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 214289 · TWI PHARMS
- 2021MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 208315 · ALKEM LABS LTD
- 2019MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 211173 · CONCORD BIOTECH LTD
- 2017MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 202555 · ACCORD HLTHCARE
- 2014MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 202720 · TEVA PHARMS USA
- 2014MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 091248 · RK PHARMA
- 2012MYCOPHENOLATE SODIUMGeneric (ANDA)
ANDA 091558 · APOTEX INC
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.

