Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075250
Company: BAUSCH
Company: BAUSCH
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 | Discontinued | 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 |
---|---|---|---|---|---|---|---|
07/12/2002 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75250wd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075250_PrednisoloneTOC.cfm |