FDA Approval for PREDNISOLONE issued to LANNETT CO INC
$LCI
Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 040775
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 09/21/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
PREDNISOLONE
SYRUP;ORAL; 15MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040323 | CHARTWELL RX |
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040775 | LANNETT CO INC |
| PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040571 | PHARM ASSOC |
| PRELONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | No | AA | 089081 | TEVA |