← FDA DRUG APPROVALS
FDA ANDA · ANDA091593
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Sponsor: CIPLA LIMITED
APPLICATION
ANDA091593
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
EFAVIRENZ 200MG, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE · TABLET · ORAL
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
EFAVIRENZ 300MG, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE · TABLET · ORAL
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATENone (Tentative Approval)
EFAVIRENZ 600MG, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE · TABLET · ORAL
Approval history
2017-09-05Labeling · Supplement 19 · standardTA
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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