Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077844
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/2012 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077844s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/30/2023 | SUPPL-17 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/16/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2019 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/25/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/25/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/25/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/25/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
ABACAVIR SULFATE
TABLET;ORAL; EQ 300MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 077844 | AUROBINDO PHARMA LTD |
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 078119 | CIPLA |
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 091560 | HETERO LABS LTD III |
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 091294 | MYLAN PHARMS INC |
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | TABLET;ORAL | Prescription | No | AB | 091050 | STRIDES PHARMA |