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FDA ANDA · ANDA204572

RIVASTIGMINE TARTRATE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA204572
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-25
LATEST ACTION
2019-04-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2019-04-04Labeling · Supplement 5 · standardAP
2019-04-04Labeling · Supplement 2 · standardAP
2016-03-25UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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