Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211271
Company: ALVOGEN
Company: ALVOGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | 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 |
---|---|---|---|---|---|---|---|
07/27/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PYRIMETHAMINE
TABLET;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DARAPRIM | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 008578 | TILDE SCIENCES |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 211271 | ALVOGEN |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 216983 | AUROBINDO PHARMA LTD |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 207127 | CEROVENE INC |
PYRIMETHAMINE | PYRIMETHAMINE | 25MG | TABLET;ORAL | Prescription | No | AB | 215506 | TEVA PHARMS |