U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204077
Company: ZHEJIANG HISUN PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2017 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/13/2024 SUPPL-7 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/06/2024 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/06/2024 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
08/11/2021 SUPPL-4 REMS - MODIFIED - D-N-A

Label is not available on this site.
04/21/2021 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.
01/15/2021 SUPPL-2 REMS - MODIFIED - D-N-A

Label is not available on this site.
06/19/2019 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

MYCOPHENOLATE MOFETIL

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CELLCEPT MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription Yes AB 050722 ROCHE PALO
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 090253 ACCORD HLTHCARE
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 200197 ALKEM LABS LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 217828 AUROBINDO PHARMA LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 210181 CONCORD BIOTECH LTD
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 207022 HETERO LABS LTD V
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065410 HIKMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065520 MYLAN
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065379 SANDOZ
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 090055 STRIDES PHARMA
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 065491 TEVA PHARMS
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 214079 WUXI
MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL 250MG CAPSULE;ORAL Prescription No AB 204077 ZHEJIANG HISUN PHARM
Back to Top