Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065211
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG 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 |
|---|---|---|---|---|---|---|---|
| 11/14/2005 | 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-34 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/14/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2016 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2015 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/03/2014 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/25/2013 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2012 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2012 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2011 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/26/2010 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/19/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/30/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/27/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
AZITHROMYCIN
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 215772 | ACI |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 211791 | ALEMBIC |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 207370 | AUROBINDO PHARMA LTD |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 210000 | BIONPHARMA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065404 | CHARTWELL RX |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 208250 | CSPC OUYI |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065398 | LUPIN LTD |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065225 | PLIVA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065211 | SANDOZ |
| AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 209045 | SUNSHINE |
| ZITHROMAX | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | Yes | AB | 050711 | PFIZER |