Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019157
Company: PAI HOLDINGS
Company: PAI HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PEDIAPRED | PREDNISOLONE SODIUM PHOSPHATE | EQ 5MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019157s025lbl.pdf | |
| 02/05/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019157s021lbl.pdf | |
| 02/05/2018 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019157s021lbl.pdf | |
| 10/08/2013 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019157s020lbl.pdf | |
| 12/03/2004 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19157s018lbl.pdf |