Subsys

NDA 202788, held by Btcp Pharma. Fentanyl.

As of Nov 14, 2026, NDA 202788 (Subsys), held by Btcp Pharma, was first approved by FDA on Jan 4, 2012, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 4, 2012
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jan 4, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Letter

Products

7 strengths and forms


Subsys0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;sublingual	Fentanyl	DiscontinuedReference drug
Subsys0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;sublingual	Fentanyl	DiscontinuedReference drug
Subsys0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;sublingual	Fentanyl	DiscontinuedReference drug
Subsys0.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;sublingual	Fentanyl	DiscontinuedReference drug
Subsys0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;sublingual	Fentanyl	DiscontinuedReference drug
Subsys1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;sublingual	Fentanyl	DiscontinuedReference drug
Subsys1.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · spray;sublingual	Fentanyl	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Dec 8, 2022	Supplement 30REMS	Approved	Letter
Aug 17, 2022	Supplement 29REMS	Approved	Letter
Dec 3, 2021	Supplement 28REMS	Approved	Letter
Mar 4, 2021	Supplement 23Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 23, 2020	Supplement 21REMS	Approved	Letter
Oct 7, 2019	Supplement 20Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 7, 2017	Supplement 18REMS	Approved	Letter
Dec 16, 2016	Supplement 16Labeling · Standard review	Approved	Medication Guide Letter Label
Nov 9, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 12, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 9, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 24, 2014	Supplement 12REMS	Approved	Label Letter
Dec 24, 2014	Supplement 11Manufacturing · Standard review	Approved	Label Letter
Dec 24, 2014	Supplement 9Labeling · Standard review	Approved	Label Letter
Nov 7, 2013	Supplement 10REMS	Approved	Letter
Jul 31, 2013	Supplement 6Labeling · Standard review	Approved	Label Letter
Jul 31, 2013	Supplement 5Labeling · Standard review	Approved	Label Letter
Aug 30, 2012	Supplement 2Labeling · Standard review	Approved	Letter Label
Jun 5, 2012	Supplement 3REMS	Approved	Label Letter
Jun 5, 2012	Supplement 1Labeling · Standard review	Approved	Label Letter
Jan 4, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Letter

Identifiers

Application: NDA 202788
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