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PREDNISOLONE SODIUM PHOSPHATE

ANDA

PREDNISOLONE SODIUM PHOSPHATE | A075099 | PHARMOBEDIENT CONSULTING

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from We Pharmaceuticals, Inc. FDA-1996-P-0316 We Pharmaceuticals, Inc. filed a suitability petition on December 13, 1996, requesting the FDA to determine that a 20.1mg Prednisolone Sodium Phosphate USP oral liquid formulation (15mg prednisolone base per 5ml) is suitable for an Abbreviated New Drug Application, as being similar and related to th	Other	2017-05-04	Open	We Pharmaceuticals

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 28, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 5MG BASE/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jun 28, 2002

No patent or exclusivity listings for this strength.