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DOLUTEGRAVIR SODIUM

NDA · New Drug Application · Sponsor: MACLEODS PHARMS LTD · Approved 2021-03-16

Drug application

FDA Application #

NDA214566

Application type

New Drug Application

Brand name

DOLUTEGRAVIR SODIUM

Generic name

Dolutegravir Sodium

Active ingredients

DOLUTEGRAVIR SODIUM

Dosage form

TABLET

Route

ORAL SUSPENSION

Marketing status

None (Tentative Approval)

Sponsor

MACLEODS PHARMS LTD

First approval

2021-03-16

Source

Authoritative

Drugs@FDA application overview

Machine

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