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FDA NDA · NDA022569

LAZANDA

Sponsor: BTCP PHARMA

APPLICATION
NDA022569
TYPE
NDA
ORIGINAL APPROVAL
2011-06-30
LATEST ACTION
2022-12-08
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued

Products

LAZANDA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL
LAZANDA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL
LAZANDA · ReferenceDiscontinued
FENTANYL CITRATE EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL

Approval history

2022-12-08REMS · Supplement 33 — Letter ↗AP
2022-08-17REMS · Supplement 32 — Letter ↗AP
2021-12-03REMS · Supplement 31 — Letter ↗AP
2021-03-04Labeling · Supplement 30 · standard — Letter ↗AP
2020-12-23REMS · Supplement 29 — Letter ↗AP
2019-10-07Labeling · Supplement 27 · standard — Letter ↗AP
2017-09-07REMS · Supplement 26 — Letter ↗AP
2017-03-21Labeling · Supplement 24 · standard — Label ↗AP
2016-12-16Labeling · Supplement 23 · standard — Label ↗AP
2015-12-21Manufacturing (CMC) · Supplement 22 — Letter ↗AP
2015-08-11Manufacturing (CMC) · Supplement 16 · standardAP
2014-12-24REMS · Supplement 20 — Label ↗AP
2014-12-24Labeling · Supplement 19 · standard — Letter ↗AP
2014-12-24Labeling · Supplement 13 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 21 · standardAP
2014-04-07Manufacturing (CMC) · Supplement 18 · standardAP
2013-11-07Manufacturing (CMC) · Supplement 12 · standard — Letter ↗AP
2013-11-07REMS · Supplement 17 — Letter ↗AP
2013-11-07REMS · Supplement 15 — Letter ↗AP
2012-06-05REMS · Supplement 7 — Label ↗AP
2011-12-28REMS · Supplement 5 — Label ↗AP
2011-11-04REMS · Supplement 2 — Letter ↗AP
2011-06-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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