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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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