Documents
Application Sponsors
Marketing Status
Application Products
| 001 | FOR SUSPENSION, EXTENDED RELEASE;ORAL | EQ 2GM BASE/BOT | 1 | ZMAX | AZITHROMYCIN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-06-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2008-10-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 10 | AP | 2011-06-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 12 | AP | 2011-06-07 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 2013-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2011-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2012-03-01 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2015-07-02 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2016-05-24 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2017-02-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2016-06-27 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-03-30 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 25 | AP | 2019-04-24 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2021-11-22 | STANDARD |
Submissions Property Types
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 6 |
CDER Filings
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