Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214289
Company: TWI PHARMS
Company: TWI PHARMS
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 |
---|---|---|---|---|---|---|---|
11/03/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/31/2023 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
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 | 217031 | AIRIS PHARMA PVT LTD |
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 | 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 | 217031 | AIRIS PHARMA PVT LTD |
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 | 214289 | TWI PHARMS |
MYFORTIC | MYCOPHENOLIC SODIUM | EQ 360MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050791 | NOVARTIS |