Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078800
Company: CIPLA
Company: CIPLA
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 |
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-2 | Approval | STANDARD |
Label is not available on this site. |
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01/26/2018 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078800s000TAltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/19/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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11/19/2019 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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11/19/2019 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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11/19/2019 | SUPPL-17 | Labeling-Package Insert |
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 |
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 |