Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090456
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 06/10/2010 | 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-37 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/11/2021 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-23 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/15/2021 | SUPPL-19 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/04/2020 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/22/2019 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/01/2016 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-7 | REMS-Modified |
Label is not available on this site. |
||
| 09/27/2013 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/31/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/25/2012 | SUPPL-4 | Labeling-Medication Guide |
Label is not available on this site. |
MYCOPHENOLATE MOFETIL
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CELLCEPT | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | Yes | AB | 050723 | ROCHE PALO |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065416 | ACCORD HLTHCARE |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 091249 | ALKEM LABS LTD |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 217937 | AUROBINDO PHARMA |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 212087 | CONCORD BIOTECH LTD |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 208119 | HETERO LABS LTD V |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065413 | HIKMA |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065521 | MYLAN |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 065451 | SANDOZ |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 090456 | STRIDES PHARMA |
| MYCOPHENOLATE MOFETIL | MYCOPHENOLATE MOFETIL | 500MG | TABLET;ORAL | Prescription | No | AB | 204076 | ZHEJIANG HISUN PHARM |