FDA NDA · NDA017703

CYLERT

Sponsor: ABBOTT

APPLICATION

NDA017703

TYPE

NDA

ORIGINAL APPROVAL

1976-01-30

LATEST ACTION

2003-11-21

ROUTE

ORAL

DOSAGE FORM

TABLET, CHEWABLE

MARKETING STATUS

Discontinued

Products

CYLERTDiscontinued

PEMOLINE 37.5MG · TABLET, CHEWABLE · ORAL

2003-11-21Labeling · Supplement 18 · standard — Letter ↗AP

2003-01-06Manufacturing (CMC) · Supplement 17 · priorityAP

1999-05-28Labeling · Supplement 16 · standardAP

1998-05-13Manufacturing (CMC) · Supplement 14 · priority — Review ↗AP

1997-12-12Labeling · Supplement 13 · standardAP

1996-09-09Manufacturing (CMC) · Supplement 12 · priority — Review ↗AP

1996-04-11Labeling · Supplement 11 · standard — Review ↗AP

1990-02-16Manufacturing (CMC) · Supplement 10 · priorityAP

1987-04-15Labeling · Supplement 9AP

1984-09-06Labeling · Supplement 7AP

1979-03-30Labeling · Supplement 4AP

1979-03-14Labeling · Supplement 3AP

1976-01-30Type 3 - New Dosage Form · Original · priority — Other Important Information from FDA ↗AP

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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