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FDA ANDA · ANDA090437

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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APPLICATION
ANDA090437
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
EFAVIRENZ 600MG, EMTRICITABINE 200MG, TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL

Approval history

2009-08-12OriginalLetterTA
VIEW ON DRUGS@FDA ↗

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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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