Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050693
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZITHROMAX | AZITHROMYCIN | EQ 1GM BASE/PACKET | FOR SUSPENSION;ORAL | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/22/2021 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050730s043,050693s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050693Orig1s034;050730Orig1s043ltr.pdf | |
| 04/24/2019 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050693s031,050730s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050693Orig1s031,050730Orig1s041ltr.pdf | |
| 03/29/2017 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s029,050730s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s029,050730Orig1s037ltr.pdf |
| 02/10/2017 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s27-050730s35lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s027,050730Orig1s035ltr.pdf | |
| 05/23/2016 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730Orig1s034ltr.pdf | |
| 11/05/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/2013 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730Orig1s031ltr.pdf | |
| 06/06/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf | |
| 06/06/2014 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730Orig1s029ltr.pdf | |
| 11/02/2012 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf | |
| 01/28/2011 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf | |
| 08/11/2010 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025ltr.pdf | |
| 03/06/2009 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050693s014,050730s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021ltr.pdf | |
| 10/25/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf | |
| 01/15/2004 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf |
| 03/24/2004 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf | |
| 07/22/2002 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf |
| 10/16/2002 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf |
| 11/13/2000 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.cfm | |
| 11/11/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/22/2021 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050730s043,050693s034lbl.pdf | |
| 04/24/2019 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050693s031,050730s041lbl.pdf | |
| 03/29/2017 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s029,050730s037lbl.pdf |
| 02/10/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s27-050730s35lbl.pdf | |
| 05/23/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf | |
| 06/06/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf | |
| 02/19/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf | |
| 11/02/2012 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf | |
| 06/06/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf | |
| 01/28/2011 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf | |
| 08/11/2010 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf | |
| 03/06/2009 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050693s014,050730s021lbl.pdf | |
| 10/25/2007 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf | |
| 03/24/2004 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf | |
| 11/13/2000 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf |