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DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CIPLA LIMITED · Approved 2025-06-12

Drug application

FDA Application #
ANDA210811
Application type
Abbreviated New Drug Application (Generic)
Brand name
DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE
Generic name
Abacavir || Dolutegravir || Lamivudine
Active ingredients
ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE
Dosage form
TABLET
Route
—
Marketing status
None (Tentative Approval)
Sponsor
CIPLA LIMITED
First approval
2025-06-12

Source

Authoritative
Drugs@FDA application overview
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