An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022159
Company: SEPTODONT HOLDING

Summary Review

Products on NDA 022159

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORAVERSE	PHENTOLAMINE MESYLATE	0.4MG/1.7ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022159

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022159s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022159_oraverse_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022159s000_SUMR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2016	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/18/2016	SUPPL-11	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022159s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022159Orig1s011ltr.pdf
01/26/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/26/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/05/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/09/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/09/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/09/2014	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022159

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/18/2016	SUPPL-11	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022159s011lbl.pdf

Top