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ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE

NDA · New Drug Application · Sponsor: AUROBINDO PHARMA USA · Approved 2023-08-14

Drug application

FDA Application #
NDA217070
Application type
New Drug Application
Brand name
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
Generic name
Abacavir
Active ingredients
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
AUROBINDO PHARMA USA
First approval
2023-08-14

Source

Authoritative
Drugs@FDA application overview
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