Lazanda

NDA 22569, held by Btcp Pharma. Fentanyl Citrate.

As of Nov 14, 2026, NDA 22569 (Lazanda), held by Btcp Pharma, was first approved by FDA on Jun 30, 2011, with 22 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2011
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jun 30, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Letter

Products

3 strengths and forms


LazandaEQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Fentanyl Citrate	DiscontinuedReference drug
LazandaEQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Fentanyl Citrate	DiscontinuedReference drug
LazandaEQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray, metered;nasal	Fentanyl Citrate	DiscontinuedReference drug

All 23 submissions, including labeling and manufacturing supplements


Dec 8, 2022	Supplement 33REMS	Approved	Letter
Aug 17, 2022	Supplement 32REMS	Approved	Letter
Dec 3, 2021	Supplement 31REMS	Approved	Letter
Mar 4, 2021	Supplement 30Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 23, 2020	Supplement 29REMS	Approved	Letter
Oct 7, 2019	Supplement 27Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 7, 2017	Supplement 26REMS	Approved	Letter
Mar 21, 2017	Supplement 24Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 16, 2016	Supplement 23Labeling · Standard review	Approved	Label Letter
Dec 21, 2015	Supplement 22Manufacturing	Approved	Letter
Aug 11, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 24, 2014	Supplement 20REMS	Approved	Label Letter
Dec 24, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Dec 24, 2014	Supplement 13Labeling · Standard review	Approved	Label Letter
Sep 30, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 7, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 7, 2013	Supplement 17REMS	Approved	Label Letter
Nov 7, 2013	Supplement 15REMS	Approved	Label Letter
Nov 7, 2013	Supplement 12Manufacturing · Standard review	Approved	Label Letter
Jun 5, 2012	Supplement 7REMS	Approved	Label Letter
Dec 28, 2011	Supplement 5REMS	Approved	Letter Label
Nov 4, 2011	Supplement 2REMS	Approved	Letter
Jun 30, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Letter

Identifiers

Application: NDA 22569
Drugs@FDA: Overview at FDA
Company: BTCP Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters