Integrase inhibitors

Dolutegravir Sodium and Abacavir Sulfate and Lamivudine

Approved 12 Jun 2025Tablet

The FDA lists this product in 2 strengths and forms.

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Composition

Active ingredients: ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE 300MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE 600MG · TabletANDA210811-003 · Tentative approval
ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE 300MG · TabletThis page

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA210811.

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Brand name: Dolutegravir Sodium and Abacavir Sulfate and Lamivudine
Active substance: abacavir || dolutegravir || lamivudine
Drug class: Integrase inhibitors, Antivirals for treatment of HIV infections, combinations, Nucleoside and nucleotide reverse transcriptase inhibitors
Group: Antivirals
Dosage form: Tablet
Applicant: Cipla Limited
Status: Tentative approval
FDA approval: 12 Jun 2025
Application: ANDA210811-002
RxCUI: 1546887