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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022382
Company: ZYLA

Medication Guide

Summary Review

Products on NDA 022382

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPRIX	KETOROLAC TROMETHAMINE	15.75MG/SPRAY	SPRAY, METERED;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022382

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022382s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022382s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022382_sprix_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022382Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022382s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022382Orig1s021ltr.pdf
01/22/2018	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022382Orig1s018ltr.pdf
06/10/2016	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/09/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022382Orig1s012,s013ltr.pdf
05/09/2016	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022382Orig1s012,s013ltr.pdf
05/11/2015	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/21/2014	SUPPL-9	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022382s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022382Orig1s009ltr.pdf
07/29/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/02/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022382

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022382s021lbl.pdf
01/22/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf
05/09/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf
05/09/2016	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf
05/09/2016	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf
05/09/2016	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022382s012s013lbl.pdf
04/21/2014	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022382s009lbl.pdf
05/14/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022382s000lbl.pdf

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