Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065506
Company: MYLAN ASI
Company: MYLAN ASI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/24/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2020 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/08/2020 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/17/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/23/2011 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |