Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091558
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 08/19/2014 | ORIG-2 | Approval |
Label is not available on this site. |
||||
| 08/21/2012 | 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 |
|---|---|---|---|---|---|
| 11/28/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/11/2021 | SUPPL-18 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/28/2023 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/21/2021 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 11/28/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2021 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/31/2019 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2015 | SUPPL-6 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2013 | SUPPL-2 | REMS-Modified |
Label is not available on this site. |
||
| 09/25/2012 | SUPPL-1 | REMS-Proposal |
Label is not available on this site. |
MYCOPHENOLIC SODIUM
TABLET, DELAYED RELEASE;ORAL; EQ 180MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202555 | ACCORD HLTHCARE |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 208315 | ALKEM LABS LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214376 | AMTA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091558 | APOTEX INC |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 218603 | AUROBINDO PHARMA LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214630 | BIOCON PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211173 | CONCORD BIOTECH LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091248 | RK PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 217031 | SKG PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214289 | TWI PHARMS |
| MYFORTIC | MYCOPHENOLIC SODIUM | EQ 180MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050791 | NOVARTIS |
TABLET, DELAYED RELEASE;ORAL; EQ 360MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202555 | ACCORD HLTHCARE |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 208315 | ALKEM LABS LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214376 | AMTA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091558 | APOTEX INC |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 218603 | AUROBINDO PHARMA LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214630 | BIOCON PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 211173 | CONCORD BIOTECH LTD |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091248 | RK PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 217031 | SKG PHARMA |
| MYCOPHENOLIC SODIUM | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 214289 | TWI PHARMS |
| MYFORTIC | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050791 | NOVARTIS |