Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212689
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | AB | No | No |
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/01/2021 | ORIG-2 | Approval | STANDARD |
Label is not available on this site. |
|||
| 02/28/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212689Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/04/2024 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/04/2024 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/08/2021 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
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 | 201806 | HETERO LABS LTD III |
| 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 | 090513 | AUROBINDO PHARMA |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 204131 | CHARTWELL RX |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET;ORAL | Prescription | No | AB | 212114 | LAURUS |
| 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 | PHARMOBEDIENT |
| 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 |
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 |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET;ORAL | Prescription | No | AB | 211640 | AUROBINDO PHARMA LTD |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET;ORAL | Prescription | No | AB | 201806 | HETERO LABS LTD III |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET;ORAL | Prescription | No | AB | 212689 | ZYDUS PHARMS |
| 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 |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET;ORAL | Prescription | No | AB | 211640 | AUROBINDO PHARMA LTD |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET;ORAL | Prescription | No | AB | 201806 | HETERO LABS LTD III |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET;ORAL | Prescription | No | AB | 212689 | ZYDUS PHARMS |
| 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 |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | No | AB | 211640 | AUROBINDO PHARMA LTD |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | No | AB | 201806 | HETERO LABS LTD III |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | No | AB | 212689 | ZYDUS PHARMS |
| TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET;ORAL | Prescription | Yes | AB | 021752 | GILEAD |