Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217937
Company: AUROBINDO PHARMA
Company: AUROBINDO 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 |
---|---|---|---|---|---|---|---|
02/20/2024 | ORIG-1 | Approval | STANDARD |
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 | 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 |