← FDA DRUG APPROVALS

FDA NDA · NDA217070

ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE

Sponsor: AUROBINDO PHARMA USA

APPLICATION
NDA217070
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

ABACAVIR; DOLUTEGRAVIR; LAMIVUDINENone (Tentative Approval)
ABACAVIR 60MG, DOLUTEGRAVIR 5MG, LAMIVUDINE 30MG · TABLET · ORAL

Approval history

2023-08-14Type 5 - New Formulation or New Manufacturer · Original · priority — Letter ↗TA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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