Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200197
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 06/13/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/03/2024 | SUPPL-25 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2024 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2021 | SUPPL-21 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-20 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/15/2021 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/12/2020 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2019 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-3 | REMS-Modified |
Label is not available on this site. |
||
| 10/05/2015 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2013 | SUPPL-1 | Labeling-Package Insert, REMS-Modified |
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 |