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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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