Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090647
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 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 |
---|---|---|---|---|---|---|---|
01/26/2018 | ORIG-3 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090647Orig1s000ltr.pdf | |
01/26/2018 | ORIG-2 | Approval |
Label is not available on this site. |
||||
01/26/2018 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090647s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/25/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
TENOFOVIR DISOPROXIL FUMARATE
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 |
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 |
TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 200MG | TABLET;ORAL | Prescription | No | AB | 209498 | QILU |
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 |
TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 250MG | TABLET;ORAL | Prescription | No | AB | 209498 | QILU |
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 |
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 |
TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET;ORAL | Prescription | No | AB | 206481 | CHARTWELL |
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 | 079071 | NORVIUM BIOSCIENCE |
TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET;ORAL | Prescription | No | AB | 209498 | QILU |
TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET;ORAL | Prescription | No | AB | 211337 | REYOUNG |
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 |