← FDA DRUG APPROVALS

FDA NDA · NDA202788

SUBSYS

Sponsor: BTCP PHARMA

APPLICATION
NDA202788
TYPE
NDA
ORIGINAL APPROVAL
2012-01-04
LATEST ACTION
2022-12-08
ROUTE
SUBLINGUAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Discontinued

Products

SUBSYS · ReferenceDiscontinued
FENTANYL 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY · SUBLINGUAL
SUBSYS · ReferenceDiscontinued
FENTANYL 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY · SUBLINGUAL
SUBSYS · ReferenceDiscontinued
FENTANYL 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY · SUBLINGUAL
SUBSYS · ReferenceDiscontinued
FENTANYL 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY · SUBLINGUAL
SUBSYS · ReferenceDiscontinued
FENTANYL 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY · SUBLINGUAL
SUBSYS · ReferenceDiscontinued
FENTANYL 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY · SUBLINGUAL
SUBSYS · ReferenceDiscontinued
FENTANYL 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY · SUBLINGUAL

Approval history

2022-12-08REMS · Supplement 30 — Letter ↗AP
2022-08-17REMS · Supplement 29 — Letter ↗AP
2021-12-03REMS · Supplement 28 — Letter ↗AP
2021-03-04Labeling · Supplement 23 · standard — Letter ↗AP
2020-12-23REMS · Supplement 21 — Letter ↗AP
2019-10-07Labeling · Supplement 20 · standard — Letter ↗AP
2017-09-07REMS · Supplement 18 — Letter ↗AP
2016-12-16Labeling · Supplement 16 · standard — Label ↗AP
2016-11-09Manufacturing (CMC) · Supplement 17 · standardAP
2016-02-12Manufacturing (CMC) · Supplement 14 · standardAP
2015-06-09Manufacturing (CMC) · Supplement 13 · standardAP
2014-12-24REMS · Supplement 12 — Label ↗AP
2014-12-24Labeling · Supplement 9 · standard — Letter ↗AP
2014-12-24Manufacturing (CMC) · Supplement 11 · standard — Label ↗AP
2013-11-07REMS · Supplement 10 — Letter ↗AP
2013-07-31Labeling · Supplement 6 · standard — Label ↗AP
2013-07-31Labeling · Supplement 5 · standard — Letter ↗AP
2012-08-30Labeling · Supplement 2 · standard — Label ↗AP
2012-06-05REMS · Supplement 3 — Label ↗AP
2012-06-05Labeling · Supplement 1 · standard — Label ↗AP
2012-01-04Type 3 - New Dosage Form · Original · standard — Label ↗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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