← FDA DRUG APPROVALS

FDA NDA · NDA019998

CHEMET

succimer

Sponsor: RECORDATI RARE

APPLICATION
NDA019998
TYPE
NDA
ORIGINAL APPROVAL
1991-01-30
LATEST ACTION
2024-09-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CHEMET · ReferencePrescription
SUCCIMER 100MG · CAPSULE · ORAL

Approval history

2024-09-16Labeling · Supplement 23 · standard — Letter ↗AP
2018-10-02Labeling · Supplement 21 · standard — Label ↗AP
2016-07-25Manufacturing (CMC) · Supplement 19 · priorityAP
2014-04-24Manufacturing (CMC) · Supplement 18 · priorityAP
2010-10-14Labeling · Supplement 17 · standard — Letter ↗AP
2007-07-11Labeling · Supplement 13 · standard — Letter ↗AP
1999-12-07Manufacturing (CMC) · Supplement 10 · priorityAP
1999-10-05Labeling · Supplement 11 · standardAP
1999-03-04Manufacturing (CMC) · Supplement 9 · priorityAP
1998-11-10Manufacturing (CMC) · Supplement 8 · priorityAP
1997-04-14Manufacturing (CMC) · Supplement 7 · priorityAP
1992-12-29Labeling · Supplement 6 · standardAP
1992-05-11Manufacturing (CMC) · Supplement 2 · priorityAP
1992-05-06Labeling · Supplement 3AP
1992-02-25Labeling · Supplement 4AP
1991-11-06Labeling · Supplement 1AP
1991-01-30Type 1 - New Molecular Entity · Original · priorityAP
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 →