← FDA DRUG APPROVALS

FDA ANDA · ANDA080336

PREDNISONE

Sponsor: AIPING PHARM INC

APPLICATION
ANDA080336
TYPE
ANDA
ORIGINAL APPROVAL
1972-07-13
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PREDNISONEDiscontinued
PREDNISONE 5MG · TABLET · ORAL

Approval history

2024-06-05Labeling · Supplement 50 · standardAP
1994-01-24Manufacturing (CMC) · Supplement 49AP
1989-08-03Labeling · Supplement 51AP
1989-08-03Labeling · Supplement 48AP
1987-08-11Manufacturing (CMC) · Supplement 45AP
1987-06-15Manufacturing (CMC) · Supplement 44AP
1986-07-30Manufacturing (CMC) · Supplement 42AP
1986-07-30Manufacturing (CMC) · Supplement 40AP
1986-07-30Manufacturing (CMC) · Supplement 39AP
1986-07-30Manufacturing (CMC) · Supplement 41AP
1984-10-01Manufacturing (CMC) · Supplement 36AP
1984-10-01Manufacturing (CMC) · Supplement 37AP
1984-08-23Manufacturing (CMC) · Supplement 34AP
1984-08-23Manufacturing (CMC) · Supplement 33AP
1982-10-12Manufacturing (CMC) · Supplement 32AP
1982-05-17Manufacturing (CMC) · Supplement 29AP
1982-02-26Manufacturing (CMC) · Supplement 31AP
1972-07-13OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →