← FDA DRUG APPROVALS

FDA NDA · NDA016832

CYLERT

Sponsor: ABBOTT

APPLICATION
NDA016832
TYPE
NDA
ORIGINAL APPROVAL
1975-01-27
LATEST ACTION
2003-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CYLERTDiscontinued
PEMOLINE 75MG · TABLET · ORAL
CYLERTDiscontinued
PEMOLINE 18.75MG · TABLET · ORAL
CYLERTDiscontinued
PEMOLINE 37.5MG · TABLET · ORAL

Approval history

2003-11-21Labeling · Supplement 22 · standard — Letter ↗AP
2003-01-06Manufacturing (CMC) · Supplement 21 · priorityAP
2002-09-12Manufacturing (CMC) · Supplement 20 · priorityAP
2002-09-04Manufacturing (CMC) · Supplement 19 · priorityAP
1999-05-28Labeling · Supplement 18 · standardAP
1998-05-08Manufacturing (CMC) · Supplement 16 · priority — Review ↗AP
1997-12-12Labeling · Supplement 15 · standard — Review ↗AP
1996-09-09Manufacturing (CMC) · Supplement 14 · priority — Review ↗AP
1996-04-11Labeling · Supplement 13 · standard — Review ↗AP
1990-02-16Manufacturing (CMC) · Supplement 12 · priorityAP
1987-06-15Labeling · Supplement 11AP
1984-09-06Labeling · Supplement 9AP
1979-03-30Labeling · Supplement 6AP
1979-03-14Labeling · Supplement 3AP
1978-06-06Manufacturing (CMC) · Supplement 5 · priorityAP
1977-10-12Manufacturing (CMC) · Supplement 4 · priorityAP
1975-03-25Manufacturing (CMC) · Supplement 1 · priorityAP
1975-01-27Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
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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