FDA NDA · NDA020682

GLYSET

Sponsor: PFIZER

APPLICATION

NDA020682

TYPE

NDA

ORIGINAL APPROVAL

1996-12-18

LATEST ACTION

2015-10-14

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

GLYSET · ReferenceDiscontinued

MIGLITOL 100MG · TABLET · ORAL

GLYSET · ReferenceDiscontinued

MIGLITOL 25MG · TABLET · ORAL

GLYSET · ReferenceDiscontinued

MIGLITOL 50MG · TABLET · ORAL

2015-10-14Manufacturing (CMC) · Supplement 12 · standardAP

2012-09-17Labeling · Supplement 10 · standard — Label ↗AP

2009-04-24Labeling · Supplement 8 · standard — Letter ↗AP

1999-09-29Manufacturing (CMC) · Supplement 4 · standardAP

1999-08-16Efficacy · Supplement 1 · standard — Review ↗AP

1999-04-06Manufacturing (CMC) · Supplement 2 · standardAP

1998-12-23Manufacturing (CMC) · Supplement 3 · standardAP

1996-12-18Type 1 - New Molecular Entity · Original · standard — Review ↗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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