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DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

NDA · New Drug Application · Sponsor: LUPIN PHARMS · Approved 2021-06-25

Drug application

FDA Application #
NDA212303
Application type
New Drug Application
Brand name
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Generic name
Dolutegravir
Active ingredients
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
LUPIN PHARMS
First approval
2021-06-25

Source

Authoritative
Drugs@FDA application overview
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