Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206157
Company: MICRO LABS
Company: MICRO LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 12/18/2025 | ORIG-1 | Approval | STANDARD |
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 | 206157 | MICRO LABS |
| TENOFOVIR DISOPROXIL FUMARATE | TENOFOVIR DISOPROXIL FUMARATE | 300MG | TABLET;ORAL | Prescription | No | AB | 079071 | PHARMOBEDIENT |
| 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 |