Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065218
Company: PLIVA
Company: PLIVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | AB | No | Yes |
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 |
---|---|---|---|---|---|
02/06/2023 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
11/22/2021 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
01/08/2020 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
01/08/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
01/08/2020 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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01/08/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
07/30/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
AZITHROMYCIN
TABLET;ORAL; EQ 600MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 211793 | ALEMBIC |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 209999 | BIONPHARMA |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 065302 | CHARTWELL RX |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 207566 | CSPC OUYI |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 065400 | LUPIN LTD |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 065218 | PLIVA |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 065209 | SANDOZ |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 209043 | SUNSHINE |
AZITHROMYCIN | AZITHROMYCIN | EQ 600MG BASE | TABLET;ORAL | Prescription | No | AB | 211068 | YUNG SHIN PHARM |