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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206494
Company: ALLERGAN

Summary Review

Products on NDA 206494

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVYCAZ	AVIBACTAM SODIUM; CEFTAZIDIME	EQ 0.5GM BASE;2GM/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206494

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2015	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206494Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206494Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2024	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206494s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206494Orig1s012ltr.pdf
12/20/2022	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206494s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206494Orig1s011ltr.pdf
12/07/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206494s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206494Orig1s007ltr.pdf
03/14/2019	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206494s005,s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206494Orig1s005, 206494Orig1s006ltr.pdf
03/14/2019	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206494s005,s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206494Orig1s005, 206494Orig1s006ltr.pdf
02/01/2018	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206494s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206494Orig1s004ltr.pdf
01/26/2017	SUPPL-3	Efficacy-Labeling Change With Clinical Data	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/2017/206494s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206494Orig1s003ltr.pdf
06/22/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206494s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206494Orig1s002ltr.pdf
09/02/2015	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206494orig1s001ltr.pdf

Labels for NDA 206494

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2024	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206494s012lbl.pdf
12/20/2022	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206494s011lbl.pdf
12/07/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206494s007lbl.pdf
03/14/2019	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206494s005,s006lbl.pdf
03/14/2019	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206494s005,s006lbl.pdf
02/01/2018	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206494s004lbl.pdf
01/26/2017	SUPPL-3	Efficacy-Labeling Change With Clinical Data	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/2017/206494s003lbl.pdf
06/22/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206494s002lbl.pdf
09/02/2015	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s001lbl.pdf
09/02/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s001lbl.pdf
02/25/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206494s000lbl.pdf

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