Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218419
Company: ANNORA PHARMA
Company: ANNORA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISINOPRIL | LISINOPRIL | 1MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 08/20/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
LISINOPRIL
SOLUTION;ORAL; 1MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISINOPRIL | LISINOPRIL | 1MG/ML | SOLUTION;ORAL | Prescription | No | AA | 218419 | ANNORA PHARMA |
| QBRELIS | LISINOPRIL | 1MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 208401 | AZURITY |