Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203005
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 | 200MG/ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 11/14/2014 | 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 |
|---|---|---|---|---|---|
| 05/08/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2021 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/15/2021 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 03/08/2022 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/25/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2019 | SUPPL-6 | Labeling-Package Insert, Labeling-Proprietary Name Change |
Label is not available on this site. |
||
| 01/11/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2015 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-1 | REMS-Modified |
Label is not available on this site. |
MYCOPHENOLATE MOFETIL
FOR SUSPENSION;ORAL; 200MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELLCEPT | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050759 | ROCHE PALO |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 203005 | ALKEM LABS LTD |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 214871 | AMNEAL |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 213955 | HETERO LABS LTD V |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 214525 | LANNETT CO INC |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 212634 | STRIDES PHARMA |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211272 | TEVA PHARMS USA |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 200MG/ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210370 | VISTAPHARM |