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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019157
Company: SETON PHARM

Products on NDA 019157

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019157

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-Package Insert, Labeling-Container/Carton Labels	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.

Labels for NDA 019157

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

Therapeutic Equivalents for NDA 019157

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

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