Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212541
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYRAZINAMIDE | PYRAZINAMIDE | 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 |
---|---|---|---|---|---|---|---|
07/27/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PYRAZINAMIDE
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PYRAZINAMIDE | PYRAZINAMIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 081319 | HIKMA |
PYRAZINAMIDE | PYRAZINAMIDE | 500MG | TABLET;ORAL | Prescription | No | AB | 212541 | MACLEODS PHARMS LTD |
PYRAZINAMIDE | PYRAZINAMIDE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 080157 | NOVITIUM PHARMA |