Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040571
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SYRUP;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
08/25/2005 | 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-4 | 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 |