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PEDIAPRED

NDA

PREDNISOLONE SODIUM PHOSPHATE | N019157 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI FRANCEPREDNISOLONE SODIUM PHOSPHATE

DMF 40511981

CURIA SPAIN SAUPREDNISOLONE SODIUM PHOSPHATE

DMF 226242009

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 238992010

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 297512015

FARMABIOS SPAPREDNISOLONE SODIUM PHOSPHATE

DMF 401172024

ORGANON INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 7581963

ANTIBIOTICOS SPAInactivePREDNISOLONE SODIUM PHOSPHATE BULK

DMF 23761974

DIOSYNTHInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 38191980

PFIZER INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 93071991

NEWCHEM SPAInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 218222008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jun 7, 2024	SUPPL -25	View Letter (PDF)
Feb 8, 2018	SUPPL -21	View Letter (PDF)
Oct 10, 2013	SUPPL -20	View Letter (PDF)
Dec 8, 2004	SUPPL -18	View Letter (PDF)
Dec 17, 1998	SUPPL -12	View Letter (PDF)
Dec 17, 1998	SUPPL -11	View Letter (PDF)
Dec 17, 1998	SUPPL -15	View Letter (PDF)
Dec 17, 1998	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 5MG BASE/5ML

RLDAA

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: May 28, 1986

No patent or exclusivity listings for this strength.