← FDA DRUG APPROVALS

FDA NDA · NDA017469

PREDNISOLONE ACETATE

Sponsor: SANDOZ

APPLICATION
NDA017469
TYPE
NDA
ORIGINAL APPROVAL
1973-07-10
LATEST ACTION
2024-12-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

OMNIPRED · ReferencePrescription
PREDNISOLONE ACETATE 1% · SUSPENSION/DROPS · OPHTHALMIC

Approval history

2024-12-18Labeling · Supplement 54 · standard — Label ↗AP
2022-03-04Labeling · Supplement 47 · standard — Letter ↗AP
2007-10-11Labeling · Supplement 40 · standard — Letter ↗AP
2006-05-15Labeling · Supplement 35 · standard — Letter ↗AP
2006-05-15Labeling · Supplement 38 · standard — Label ↗AP
2003-04-17Labeling · Supplement 31 · standard — Letter ↗AP
2002-12-11Manufacturing (CMC) · Supplement 30 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 29 · standardAP
2000-05-16Manufacturing (CMC) · Supplement 28 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 27 · standardAP
1999-04-05Manufacturing (CMC) · Supplement 26 · standardAP
1999-03-09Manufacturing (CMC) · Supplement 25 · standardAP
1998-10-06Manufacturing (CMC) · Supplement 24 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 23 · standardAP
1997-06-27Manufacturing (CMC) · Supplement 22 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 21 · standardAP
1996-03-05Manufacturing (CMC) · Supplement 20 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 19 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 17 · standardAP
1995-08-29Efficacy · Supplement 18 · standardAP
1995-06-13Manufacturing (CMC) · Supplement 16 · standardAP
1991-08-22Labeling · Supplement 14AP
1991-04-10Manufacturing (CMC) · Supplement 15 · standardAP
1989-03-06Labeling · Supplement 11AP
1988-03-02Manufacturing (CMC) · Supplement 13 · standardAP
1986-03-12Manufacturing (CMC) · Supplement 12 · standardAP
1982-05-25Manufacturing (CMC) · Supplement 10 · standardAP
1979-05-24Manufacturing (CMC) · Supplement 8 · standardAP
1977-08-24Labeling · Supplement 7AP
1977-04-06Manufacturing (CMC) · Supplement 5 · standardAP
1977-04-06Manufacturing (CMC) · Supplement 3 · standardAP
1977-04-06Manufacturing (CMC) · Supplement 6 · standardAP
1977-04-06Manufacturing (CMC) · Supplement 4 · standardAP
1974-12-05Labeling · Supplement 1AP
1973-07-10Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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