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PREDNISOLONE

ANDA

PREDNISOLONE | A040423 | NESHER PHARMACEUTICALS USA LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs14 inactive

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

EUROAPI FRANCEPREDNISOLONE

DMF 35351979

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDPREDNISOLONE ANHYDROUS, USP

DMF 180632005

TIANJIN TIANYAO PHARMACEUTICALS CO LTDPREDNISOLONE USP BULK

DMF 187162005

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE HEMI SUCCINATE

DMF 246302011

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE USP (PROCESS I)

DMF 306252016

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE USP

DMF 345052020

SHANDONG XINHUA PHARMACEUTICAL CO LTDPREDNISOLONE

DMF 401292024

FARMABIOS SPAPREDNISOLONE

DMF 407552024

SYNTEX SAInactivePREDNISOLONE

DMF 2761957

PHARMACIA AND UPJOHN SUB PFIZER INCInactivePREDNISOLONE USP

DMF 14321969

BLASCHIM SPAInactivePREDNISOLONE 21 DISODIUM PHOSPHATE

DMF 28501977

DIOSYNTH BVInactivePREDNISOLONE MICRO

DMF 39451980

MEDIMPEX NORTH AMERICA INCInactivePREDNISOLONE

DMF 40481981

DIOSYNTH BVInactivePREDNISOLONE SUCCINATE

DMF 41501981

ROUSSELL UCLAFInactivePREDNISOLONE SUCCINATE (PREDNISOLONE HYDROGEN SUCCINATE)

DMF 42791981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactivePREDNISOLONE SODIUM PHOSPHATE, USP XX

DMF 46041982

SCHERING AGInactivePREDNISOLONE 21-HEMISUCCINATE

DMF 47861982

SCHERING AGInactivePREDNISOLONE

DMF 48311982

SCHERING AGInactivePREDNISOLONE 21-DISODIUM PHOSPHATE

DMF 55831984

TIANJIN PHARMACEUTICAL CORPInactivePREDNISOLONE

DMF 112181994

SANOFI CHIMIEInactivePREDNISOLONE SODIUM METASULFOBENZOATE

DMF 156522001

HENAN LIHUA PHARMACEUTICAL CO LTDInactivePREDNISOLONE

DMF 247952011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Oct 22, 2001

No patent or exclusivity listings for this strength.