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FDA NDA · NDA214566

DOLUTEGRAVIR SODIUM

Sponsor: MACLEODS PHARMS LTD

APPLICATION
NDA214566
TYPE
NDA
ROUTE
ORAL SUSPENSION
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

DOLUTEGRAVIR SODIUMNone (Tentative Approval)
DOLUTEGRAVIR SODIUM 10MG · TABLET · ORAL SUSPENSION

Approval history

2021-03-16Type 5 - New Formulation or New Manufacturer · Original · priorityLetterTA
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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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