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DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE

NDA · New Drug Application · Sponsor: CIPLA USA INC. · Approved 2022-03-30

Drug application

FDA Application #
NDA212527
Application type
New Drug Application
Brand name
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
Generic name
Dolutegravir Lamivudine Tenofovir Alafenamide
Active ingredients
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE
Dosage form
TABLET
Route
—
Marketing status
None (Tentative Approval)
Sponsor
CIPLA USA INC.
First approval
2022-03-30

Source

Authoritative
Drugs@FDA application overview
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