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ANDA

PREDNISOLONE SODIUM PHOSPHATE | A075117 | CONCORDIA PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Cohen, Tauber, Spievack & Wagner P.C - Citizen Petition FDA-2008-P-0584 · 3 docket documents Cohen, Tauber, Spievack & Wagner P.C. filed this citizen petition on October 31, 2008 under Section 505(j)(2)(C) requesting that the FDA determine that prednisolone sodium phosphate oral solution at 30 mg per 5 mL of equivalent prednisolone base is suitable for submission as an abbreviated new drug	Other	2008-12-30	Granted	—

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

API Supply Chain5 active DMFs6 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

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactivePREDNISOLONE SODIUM PHOSPHATE, USP XX

DMF 46041982

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
Dec 14, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 14, 2000

No patent or exclusivity listings for this strength.