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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204287
Company: MACLEODS PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/13/2021 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204287Orig1s000TAltr.pdf

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 600MG;200MG;300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATRIPLA EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription Yes AB 021937 GILEAD SCIENCES
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 203041 AUROBINDO PHARMA LTD
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 206894 CIPLA
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 203053 HETERO LABS LTD V
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 213541 LAURUS
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 204287 MACLEODS PHARMS LTD
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;200MG;300MG TABLET;ORAL Prescription No AB 091215 TEVA PHARMS USA
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