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PREDNISOLONE SODIUM PHOSPHATE

ANDA

PREDNISOLONE SODIUM PHOSPHATE | A076913 | PHARMACEUTICAL ASSOC INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: PEDIAPRED(TE code: AA)

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lowenstein Sandler on behalf of PAI Holdings, LLC dba P... FDA-2026-P-7013 Law firm Lowenstein Sandler on behalf of PAI Holdings LLC dba Pharmaceutical Associates Inc. and PAI Pharma filed this citizen petition requesting the FDA Commissioner investigate the stability and safety of Kesin Pharma's repackaged Prednisolone Sodium Phosphate Oral Solution 15 mg/5 mL unit-dose c	505(q)	2026-06-24	Open	Lowenstein Sandler on behalf of PAI Holdings

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

Products (1)

#001 — EQ 15MG BASE/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Apr 25, 2005

No patent or exclusivity listings for this strength.