Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076913
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/25/2005 | 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-14 | Labeling-Package Insert |
Label is not available on this site. |
||
04/16/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
06/02/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/05/2007 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
PREDNISOLONE SODIUM PHOSPHATE
SOLUTION;ORAL; EQ 15MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 216715 | AMNEAL |
PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 203559 | EDENBRIDGE PHARMS |
PREDNISOLONE SODIUM PHOSPHATE | PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 076913 | PHARM ASSOC |