Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206151
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;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 |
|---|---|---|---|---|---|---|---|
| 03/28/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/27/2020 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/27/2020 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
ABACAVIR SULFATE AND LAMIVUDINE
TABLET;ORAL; EQ 600MG BASE;300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 090159 | AUROBINDO PHARMA LTD |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 206151 | AUROBINDO PHARMA LTD |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 091144 | CIPLA |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 204990 | LUPIN LTD |
| ABACAVIR SULFATE AND LAMIVUDINE | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | No | AB | 079246 | TEVA PHARMS USA |
| EPZICOM | ABACAVIR SULFATE; LAMIVUDINE | EQ 600MG BASE;300MG | TABLET;ORAL | Prescription | Yes | AB | 021652 | VIIV HLTHCARE |
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