← FDA DRUG APPROVALS

FDA NDA · NDA019157

PREDNISOLONE SODIUM PHOSPHATE

Sponsor: PAI HOLDINGS

APPLICATION
NDA019157
TYPE
NDA
ORIGINAL APPROVAL
1986-05-28
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PEDIAPRED · ReferencePrescription
PREDNISOLONE SODIUM PHOSPHATE EQ 5MG BASE/5ML · SOLUTION · ORAL

Approval history

2024-06-05Labeling · Supplement 25 · standard — Label ↗AP
2018-02-05Labeling · Supplement 21 · standard — Label ↗AP
2013-10-08Labeling · Supplement 20 · standard — Letter ↗AP
2004-12-03Labeling · Supplement 18 · standard — Label ↗AP
2002-01-03Manufacturing (CMC) · Supplement 17 · standardAP
1998-12-17Labeling · Supplement 11 · standard — Letter ↗AP
1998-12-17Labeling · Supplement 12 · standard — Letter ↗AP
1998-12-17Efficacy · Supplement 15 · standard — Letter ↗AP
1998-12-17Labeling · Supplement 13 · standard — Letter ↗AP
1998-01-21Labeling · Supplement 16 · standard — Review ↗AP
1997-05-29Manufacturing (CMC) · Supplement 14 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 10 · standardAP
1993-11-22Labeling · Supplement 9 · standardAP
1993-11-08Manufacturing (CMC) · Supplement 8 · standardAP
1989-10-27Manufacturing (CMC) · Supplement 6 · standardAP
1989-02-02Manufacturing (CMC) · Supplement 4 · standardAP
1988-10-31Manufacturing (CMC) · Supplement 5 · standardAP
1986-08-14Manufacturing (CMC) · Supplement 1 · standardAP
1986-05-28Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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