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DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

NDA · New Drug Application · Sponsor: STRIDES PHARMA · Approved 2023-09-14

Drug application

FDA Application #
NDA217016
Application type
New Drug Application
Brand name
DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE
Generic name
Dolutegravir
Active ingredients
DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
STRIDES PHARMA
First approval
2023-09-14

Source

Authoritative
Drugs@FDA application overview
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