FDA NDA · NDA021006

FROVA

Sponsor: ENDO OPERATIONS

APPLICATION

NDA021006

TYPE

NDA

ORIGINAL APPROVAL

2001-11-08

LATEST ACTION

2018-08-20

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

FROVA · ReferenceDiscontinued

FROVATRIPTAN SUCCINATE EQ 2.5MG BASE · TABLET · ORAL

2018-08-20Labeling · Supplement 22 · standard — Label ↗AP

2016-11-15Manufacturing (CMC) · Supplement 21 · standardAP

2014-09-30Manufacturing (CMC) · Supplement 18 · standardAP

2013-10-11Labeling · Supplement 19 · standard — Letter ↗AP

2013-09-27Manufacturing (CMC) · Supplement 20 · standardAP

2009-03-03Labeling · Supplement 9 · standard — Letter ↗AP

2009-03-03Labeling · Supplement 6 · standard — Letter ↗AP

2009-03-03Labeling · Supplement 10 · standard — Label ↗AP

2005-09-26Labeling · Supplement 5 · standardAP

2001-11-08Type 1 - New Molecular Entity · Original · standard — 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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