Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091612
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription AB No No
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription AB No No
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription AB No No
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG 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
03/18/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091612Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2017 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

10/24/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

01/26/2018 SUPPL-1

Label is not available on this site.

TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 209550 CASI PHARMS INC
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 078800 CIPLA
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 090636 HETERO LABS LTD III
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 203232 MACLEODS PHARMS LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 209498 QILU PHARM CO LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 090742 STRIDES PHARMA
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 209498 QILU PHARM CO LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 090647 AUROBINDO PHARMA LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 206569 MYLAN
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 209498 QILU PHARM CO LTD
TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription No AB 091612 TEVA PHARMS USA
VIREAD TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET;ORAL Prescription Yes AB 021356 GILEAD SCIENCES INC

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