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FDA ANDA · ANDA077131

RIVASTIGMINE TARTRATE

Sponsor: SUN PHARM

APPLICATION
ANDA077131
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-22
LATEST ACTION
2019-04-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 6MG BASE · CAPSULE · ORAL
RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 3MG BASE · CAPSULE · ORAL
RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 4.5MG BASE · CAPSULE · ORAL
RIVASTIGMINE TARTRATEDiscontinued
RIVASTIGMINE TARTRATE EQ 1.5MG BASE · CAPSULE · ORAL

Approval history

2019-04-16Labeling · Supplement 6 · standardAP
2019-04-16Labeling · Supplement 10 · standardAP
2015-11-17Labeling · Supplement 4 · standardAP
2007-10-22OriginalLetterAP
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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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