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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.

PREDNISOLONE ACETATE

ANDA

Tentative Approval

PREDNISOLONE ACETATE | A212778 | UPSHER SMITH LABS

API Supply Chain3 active DMFs2 inactive

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

EUROAPI FRANCEPREDNISOLONE ACETATE

DMF 35291979

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE ACETATE USP

DMF 285182014

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE ACETATE USP

DMF 327282018

DIOSYNTH BVInactivePREDNISOLONE ACETATE MICRO

DMF 39491980

PFIZER INCInactivePREDNISOLONE ACETATE USP,MICRO & NON MICRO

DMF 55041984

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

Products (1)

#001 — 1%

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SUSPENSION/DROPS;OPHTHALMIC | Approved: 2026-09-28 00:00:00

No patent or exclusivity listings for this strength.