Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201570
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABACAVIR SULFATE | ABACAVIR SULFATE | EQ 300MG BASE | TABLET;ORAL | Discontinued | None | 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 | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2021 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/26/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/26/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/26/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |