FDA NDA · NDA022386

PRANDIMET

Sponsor: NOVO NORDISK INC

APPLICATION

NDA022386

TYPE

NDA

ORIGINAL APPROVAL

2008-06-23

LATEST ACTION

2017-12-08

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

PRANDIMET · ReferenceDiscontinued

METFORMIN HYDROCHLORIDE 500MG, REPAGLINIDE 2MG · TABLET · ORAL

PRANDIMET · ReferenceDiscontinued

METFORMIN HYDROCHLORIDE 500MG, REPAGLINIDE 1MG · TABLET · ORAL

2017-12-08Labeling · Supplement 16 · standard — Label ↗AP

2017-04-05Labeling · Supplement 18 · standard — Label ↗AP

2014-07-29Manufacturing (CMC) · Supplement 13 · standardAP

2014-06-11Manufacturing (CMC) · Supplement 12 · standardAP

2014-06-04Manufacturing (CMC) · Supplement 14 · standardAP

2014-06-04Manufacturing (CMC) · Supplement 15 · standardAP

2013-10-17Manufacturing (CMC) · Supplement 9 · standardAP

2013-10-17Manufacturing (CMC) · Supplement 11 · standardAP

2012-04-24Labeling · Supplement 8 · standard — Label ↗AP

2012-03-01Labeling · Supplement 7 · standard — Letter ↗AP

2010-05-28Labeling · Supplement 2 · unknown — Label ↗AP

2008-06-23Type 4 - New Combination · 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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