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FDA ANDA · ANDA202461

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA202461
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNone (Tentative Approval)
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMNone (Tentative Approval)
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2018-09-04UNKNOWN · OriginalTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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