Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050710
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZITHROMAX | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | Yes | No |
| ZITHROMAX | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/19/1995 | 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-51 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050670Orig1s036;050710Orig1s051;050711Orig1s050;050784Orig1s037ltr.pdf | |
| 04/24/2019 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050710s049,050711s047,050784s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050710Orig1s049,050711Orig1s047,050784Orig1s034ltr.pdf | |
| 03/30/2017 | SUPPL-46 | 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/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050670Orig1s032,050710Orig1s046,050711Orig1s043,050784Orig1s030ltr.pdf |
| 02/10/2017 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050710Orig1s044,050711Orig1s041,050784Orig1s028ltr.pdf | |
| 05/23/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050710Orig1s043,050711Orig1s040,050784Orig1s027ltr.pdf | |
| 02/19/2013 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050710s039,050711s036,050784s023ltr.pdf | |
| 06/06/2012 | SUPPL-38 | 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 | |
| 06/07/2014 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050710Orig1s037,050711Orig1s034,050784Orig11s021ltr.pdf | |
| 11/02/2012 | SUPPL-34 | 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-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf | |
| 08/11/2010 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050710s032,050711s030,050784s017ltr.pdf | |
| 03/06/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050710s028,050711s024,050784s012ltr.pdf | |
| 10/25/2007 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050710s023, 050711s019, 050784s007ltr.pdf | |
| 01/15/2004 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf | |
| 12/18/2003 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50711slr016,50710slr020,50784slr005ltr.pdf |
| 04/27/2004 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr019ltr.pdf |
| 01/15/2004 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50710slr017,021,50711slr015,017ltr.pdf | |
| 06/20/2003 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50710slr016ltr.pdf |
| 07/22/2002 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf |
| 12/10/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/2002 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50710s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-710S011_50-711S009_Zithromax.cfm | |
| 12/14/2001 | SUPPL-9 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50710s8ltr.pdf | |
| 12/14/2001 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50710s8ltr.pdf | |
| 10/16/2002 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50710slr007,50711slr008ltr.pdf |
| 11/11/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1996 | SUPPL-1 | Efficacy-New Patient Population |
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-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050670Orig1s036;050710Orig1s051;050711Orig1s050;050784Orig1s037ltr.pdf | |
| 04/24/2019 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050710s049,050711s047,050784s034lbl.pdf | |
| 03/30/2017 | SUPPL-46 | 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/2017/050670s032,050710s046,050711s043,050784s030lbl.pdf |
| 02/10/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf | |
| 05/23/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050710s043,050711s040,050784s027lbl.pdf | |
| 06/07/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050710s037,050711s034,050784s021lbl.pdf | |
| 02/19/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050710s039,050711s036,050784s023lbl.pdf | |
| 11/02/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf | |
| 06/06/2012 | SUPPL-38 | 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-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050710s033,050711s031,050784s018,.pdf | |
| 08/11/2010 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf | |
| 03/06/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050710s028,050711s024,050784s012lbl.pdf | |
| 10/25/2007 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050710s023,050711s019,050784s007lbl.pdf | |
| 01/15/2004 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf | |
| 01/15/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50710slr017,021,50711slr015,017_zithromax_lbl.pdf | |
| 05/24/2002 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50710s11lbl.pdf | |
| 12/14/2001 | SUPPL-9 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s9lbl.pdf | |
| 12/14/2001 | SUPPL-8 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50710s8lbl.pdf |
ZITHROMAX
FOR SUSPENSION;ORAL; EQ 100MG BASE/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 205666 | AMNEAL |
| AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 209201 | AUROBINDO PHARMA LTD |
| AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 207531 | EPIC PHARMA LLC |
| AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217036 | HAINAN POLY |
| AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065246 | PLIVA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211147 | ZYDUS LIFESCIENCES |
| ZITHROMAX | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050710 | PFIZER |
FOR SUSPENSION;ORAL; EQ 200MG BASE/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 205666 | AMNEAL |
| AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 209201 | AUROBINDO PHARMA LTD |
| AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 207531 | EPIC PHARMA LLC |
| AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217036 | HAINAN POLY |
| AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065246 | PLIVA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 211147 | ZYDUS LIFESCIENCES |
| ZITHROMAX | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050710 | PFIZER |