Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG 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 |
---|---|---|---|---|---|
05/27/2022 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
01/08/2020 | SUPPL-32 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
02/14/2019 | SUPPL-28 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
11/12/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
01/05/2017 | SUPPL-25 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/14/2015 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2014 | SUPPL-22 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/25/2013 | 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. |
||
10/09/2012 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
07/05/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
03/26/2010 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
02/19/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
04/30/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
05/08/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |
AZITHROMYCIN
TABLET;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 215773 | ACI |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 211792 | ALEMBIC |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 207398 | AUROBINDO PHARMA LTD |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 210001 | BIONPHARMA |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065405 | CHARTWELL RX |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 208249 | CSPC OUYI |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065399 | LUPIN LTD |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065223 | PLIVA |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065212 | SANDOZ |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 209044 | SUNSHINE |
AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 065193 | TEVA |
ZITHROMAX | AZITHROMYCIN | EQ 500MG BASE | TABLET;ORAL | Prescription | Yes | AB | 050784 | PFIZER |