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FDA ANDA · ANDA207457

SUMATRIPTAN AND NAPROXEN SODIUM

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA207457
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-15
LATEST ACTION
2020-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SUMATRIPTAN AND NAPROXEN SODIUMPrescription
NAPROXEN SODIUM 500MG, SUMATRIPTAN SUCCINATE EQ 85MG BASE · TABLET · ORAL

Approval history

2020-06-24Labeling · Supplement 6 · standardAP
2018-02-15UNKNOWN · Original · standardLetterAP
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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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