← FDA DRUG APPROVALS

FDA NDA · NDA217016

DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE

Sponsor: STRIDES PHARMA

APPLICATION
NDA217016
TYPE
NDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINENone (Tentative Approval)
DOLUTEGRAVIR 50MG/300MG/300MG, TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE · TABLET · ORAL

Approval history

2023-09-14New Combination and New Formulation or New Manufacturer · Original · standard — 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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