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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050797
Company: PF PRISM CV

Other Important Information from FDA

Products on NDA 050797

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050797

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-Package Insert, Labeling-Patient 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

Labels for NDA 050797

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf
02/19/2013	SUPPL-17	Labeling-Patient 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

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