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PREDNISOLONE ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2026-09-28

Drug application

FDA Application #
ANDA212778
Application type
Abbreviated New Drug Application (Generic)
Brand name
PREDNISOLONE ACETATE
Generic name
Prednisolone Acetate
Active ingredients
PREDNISOLONE ACETATE
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
Marketing status
Prescription
Sponsor
UPSHER SMITH LABS
First approval
2026-09-28

Source

Authoritative
Drugs@FDA application overview
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