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ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMACEUTICALS LTD · Approved 2025-09-17

Drug application

FDA Application #
ANDA217830
Application type
Abbreviated New Drug Application (Generic)
Brand name
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
Generic name
Abacavir, Dolutegravir, Lamivudine
Active ingredients
ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
Dosage form
TABLET
Route
—
Marketing status
None (Tentative Approval)
Sponsor
MACLEODS PHARMACEUTICALS LTD
First approval
2025-09-17

Source

Authoritative
Drugs@FDA application overview
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