Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214467
Company: ANNORA PHARMA
Company: ANNORA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
02/24/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ENALAPRIL MALEATE
SOLUTION;ORAL; 1MG/ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AB | 213714 | ALKEM LABS LTD |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AB | 212894 | AMNEAL |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AB | 214467 | ANNORA PHARMA |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AB | 216458 | AUROBINDO PHARMA |
ENALAPRIL MALEATE | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | No | AB | 212408 | BIONPHARMA |
EPANED | ENALAPRIL MALEATE | 1MG/ML | SOLUTION;ORAL | Prescription | Yes | AB | 208686 | AZURITY |