Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205787
Company: KALEO INC

• Summary Review

Products on NDA 205787

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVZIO	NALOXONE HYDROCHLORIDE	0.4MG/0.4ML (0.4MG/0.4ML)	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205787

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2014	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205787Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205787Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205787Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205787Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/06/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/11/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205787

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205787Orig1s000lbl.pdf