Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050733
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZITHROMAX | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050733Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050733ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/22/2021 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050733s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050733Orig1s050ltr.pdf | |
| 01/06/2022 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050733Orig1s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050733Orig1s049ltr.pdf | |
| 04/24/2019 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050733s047lbl.pdf | |
| 03/29/2017 | SUPPL-46 | Labeling |
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/2017/050733s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050733Orig1s046ltr.pdf |
| 02/10/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050733Orig1s043ltr.pdf | |
| 05/24/2016 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050733s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050733Orig1s040ltr.pdf | |
| 06/24/2014 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/2013 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050733s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050733Orig1s035ltr.pdf | |
| 06/06/2012 | SUPPL-34 | 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 | |
| 11/16/2011 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050733s033ltr.pdf | |
| 06/06/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050733s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050733Orig1s031ltr.pdf | |
| 01/28/2011 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s030.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf | |
| 08/11/2010 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050733s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050733s029ltr.pdf | |
| 03/06/2009 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050733s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050733s023ltr.pdf | |
| 10/25/2007 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050733s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050733s018ltr.pdf | |
| 01/15/2004 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr013ltr.pdf |
| 01/15/2004 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50733slr012ltr.pdf |
| 07/22/2002 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf |
| 03/13/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733s9ltr.pdf |
| 12/10/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2003 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50733slr007ltr.pdf |
| 10/16/2002 | SUPPL-6 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50733slr006ltr.pdf |
| 02/28/2001 | SUPPL-5 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50733s5lbl.pdf | |
| 11/11/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/22/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/06/2022 | SUPPL-49 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050733Orig1s049lbl.pdf | |
| 11/22/2021 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050733s050lbl.pdf | |
| 04/24/2019 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050733s047lbl.pdf | |
| 03/29/2017 | SUPPL-46 | Labeling | 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/2017/050733s046lbl.pdf |
| 02/10/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050733s043lbl.pdf | |
| 05/24/2016 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050733s040lbl.pdf | |
| 06/06/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050733s031lbl.pdf | |
| 02/19/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050733s035lbl.pdf | |
| 06/06/2012 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf | |
| 11/16/2011 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s033lbl.pdf | |
| 01/28/2011 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050733s030.pdf | |
| 08/11/2010 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050733s029lbl.pdf | |
| 03/06/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050733s023lbl.pdf | |
| 10/25/2007 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050733s018lbl.pdf | |
| 02/28/2001 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50733s5lbl.pdf |
ZITHROMAX
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203294 | EUGIA PHARMA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065179 | FRESENIUS KABI USA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065501 | GLAND PHARMA LTD |
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065500 | HOSPIRA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065511 | HOSPIRA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203412 | SLATE RUN PHARMA |
| AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 090923 | SUN PHARM INDS LTD |
| ZITHROMAX | AZITHROMYCIN | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050733 | PFIZER |