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FDA ANDA · ANDA214397

DOLUTEGRAVIR SODIUM

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA214397
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

DOLUTEGRAVIR SODIUMNone (Tentative Approval)
DOLUTEGRAVIR SODIUM EQ 25MG BASE · TABLET · ORAL
DOLUTEGRAVIR SODIUMNone (Tentative Approval)
DOLUTEGRAVIR SODIUM EQ 50MG BASE · TABLET · ORAL
DOLUTEGRAVIR SODIUMNone (Tentative Approval)
DOLUTEGRAVIR SODIUM EQ 10MG BASE · TABLET · ORAL

Approval history

2021-03-22UNKNOWN · Original · standardTA
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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