Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204077
Company: ZHEJIANG HISUN PHARM
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 |
---|---|---|---|---|---|
08/11/2021 | 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. |
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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 | 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 | 204077 | ZHEJIANG HISUN PHARM |