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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

PREDNISONE

ANDA

Tentative Approval

PREDNISONE | A218035 | DR REDDYS

API Supply Chain9 active DMFs5 inactive

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

EUROAPI FRANCEPREDNISONE

DMF 28741977

TIANJIN TIANYAO PHARMACEUTICALS CO LTDPREDNISONE USP

DMF 112891994

CURIA SPAIN SAUPREDNISONE ANHYDROUS USP

DMF 131731998

TIANJIN TIANYAO PHARMACEUTICALS CO LTDPREDNISONE ACETATE USP

DMF 139501999

HIKMA PHARMACEUTICALSPREDNISONE ANHYDROUS USP

DMF 160002002

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISONE

DMF 247492011

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISONE ACETATE

DMF 316402017

SHANDONG XINHUA PHARMACEUTICAL CO LTDPREDNISONE ACETATE

DMF 344792020

SHANDONG XINHUA PHARMACEUTICAL CO LTDPREDNISONE

DMF 354612020

SYNTEX LABORATORIES INC SUB SYNTEX CORPInactivePREDNISONE(CRUDE AND CRYSTALLINE)

DMF 2411957

ROUSSEL CORPInactivePREDNISONE

DMF 2601957

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCInactivePREDNISONE MICRONIZED, STERILIZED AND ACETATE

DMF 14121969

DIOSYNTH BVInactivePREDNISONE MICRO

DMF 39561980

UPJOHN COInactivePREDNISONE ACETATE, MICRO & NON-MICRO

DMF 54921984

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 24, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

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TABLET, DELAYED RELEASE;ORAL | TA Date: 2025-01-07 00:00:00

No patent or exclusivity listings for this strength.