Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019157
Company: SETON PHARM
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/1986 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019157_PEDIAPRED_ORIGINAL_AP.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/05/2018 SUPPL-21 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019157s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019157Orig1s021ltr.pdf
10/08/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019157s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019157Orig1s020ltr.pdf
12/03/2004 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19157s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19157s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019157_018_PrediapredTOC.cfm
01/03/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/21/1998 SUPPL-16 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-157S016.pdf
12/17/1998 SUPPL-15 Efficacy-New Patient Population Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
05/29/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1998 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
12/17/1998 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
12/17/1998 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf
05/10/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/22/1993 SUPPL-9 Labeling

Label is not available on this site.

11/08/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/31/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/02/1989 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1986 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/05/2018 SUPPL-21 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019157s021lbl.pdf
02/05/2018 SUPPL-21 Labeling-Package Insert 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

PEDIAPRED

SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PEDIAPRED PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription Yes AA 019157 SETON PHARM
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075988 CHARTWELL RX
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075183 HI TECH PHARMA
PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 075099 WOCKHARDT BIO AG

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