Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214871
Company: AMNEAL
Company: AMNEAL
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 |
---|---|---|---|---|---|---|---|
11/02/2021 | 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 |
---|---|---|---|---|---|
12/21/2022 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/21/2022 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
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 |