Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209721
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET;ORAL Prescription AB No No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET;ORAL Prescription AB No No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET;ORAL Prescription AB No No
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 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
08/22/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209721Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/01/2019 SUPPL-1 REMS - MODIFIED - D-N-A

Label is not available on this site.

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 100MG;150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET;ORAL Prescription No AB 209721 AMNEAL PHARMS CO
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;150MG TABLET;ORAL Prescription Yes AB 021752 GILEAD

TABLET;ORAL; 133MG;200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET;ORAL Prescription No AB 209721 AMNEAL PHARMS CO
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133MG;200MG TABLET;ORAL Prescription Yes AB 021752 GILEAD

TABLET;ORAL; 167MG;250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET;ORAL Prescription No AB 209721 AMNEAL PHARMS CO
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167MG;250MG TABLET;ORAL Prescription Yes AB 021752 GILEAD

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 209721 AMNEAL PHARMS CO
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 208740 APOTEX
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 090513 AUROBINDO PHARMA LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 090958 CIPLA
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 212114 LAURUS LABS LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 204131 LUPIN LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 203442 MACLEODS PHARMS LTD
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 206436 MYLAN
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 091055 STRIDES PHARMA
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 090894 TEVA PHARMS USA
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription No AB 212689 ZYDUS PHARMS
TRUVADA EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200MG;300MG TABLET;ORAL Prescription Yes AB 021752 GILEAD

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