Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050797
Company: PF PRISM CV
Company: PF PRISM CV
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZMAX | AZITHROMYCIN | EQ 2GM BASE/BOT | FOR SUSPENSION, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/10/2005 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050797lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050797ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050797s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2021 | SUPPL-26 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050797s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050797Orig1s026ltr.pdf | |
04/24/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050797s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050797Orig1s025ltr.pdf | |
03/30/2017 | SUPPL-24 | 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/2017/050797s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050797Orig1s024ltr.pdf |
06/27/2016 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/09/2017 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050797s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050797Orig1s021ltr.pdf | |
05/24/2016 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050797s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050797Orig1s020ltr.pdf | |
07/02/2015 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050797s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050797Orig1s019ltr.pdf | |
02/19/2013 | SUPPL-17 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s017ltr.pdf | |
03/01/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050797s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050797s016ltr.pdf | |
06/07/2011 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf | |
10/11/2013 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s013ltr.pdf | |
06/07/2011 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf | |
06/07/2011 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf | |
10/07/2008 | SUPPL-8 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050797s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050797s008ltr.pdf | |
10/25/2007 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050797s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050797s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/22/2021 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050797s026lbl.pdf | |
11/22/2021 | SUPPL-26 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050797s026lbl.pdf | |
04/24/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050797s025lbl.pdf | |
03/30/2017 | SUPPL-24 | 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/2017/050797s024lbl.pdf |
02/09/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050797s021lbl.pdf | |
05/24/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050797s020lbl.pdf | |
07/02/2015 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050797s019lbl.pdf | |
10/11/2013 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s013lbl.pdf | |
02/19/2013 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf | |
02/19/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf | |
03/01/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050797s016lbl.pdf | |
06/07/2011 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf | |
06/07/2011 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf | |
06/07/2011 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf | |
10/07/2008 | SUPPL-8 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050797s008lbl.pdf | |
10/25/2007 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050797s001lbl.pdf | |
06/10/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050797lbl.pdf |