SUBSYS is a Sublingual Spray in the Human Prescription Drug category. It is labeled and distributed by West Therapeutics Development, Llc. The primary component is Fentanyl.
Product ID | 71500-008_bcb74fed-6ce5-4724-e053-2995a90aa66a |
NDC | 71500-008 |
Product Type | Human Prescription Drug |
Proprietary Name | SUBSYS |
Generic Name | Fentanyl |
Dosage Form | Spray |
Route of Administration | SUBLINGUAL |
Marketing Start Date | 2021-03-10 |
Marketing Category | NDA / |
Application Number | NDA202788 |
Labeler Name | West Therapeutics Development, LLC |
Substance Name | FENTANYL |
Active Ingredient Strength | 1 mg/1 |
Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CII |
NDC Exclude Flag | N |
Listing Certified Through | 2022-12-31 |
Marketing Start Date | 2021-03-10 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
20482-001 | SUBSYS | fentanyl |
20482-002 | SUBSYS | fentanyl |
20482-012 | SUBSYS | SUBSYS |
20482-006 | SUBSYS | SUBSYS |
20482-008 | SUBSYS | SUBSYS |
20482-004 | SUBSYS | SUBSYS |
20482-016 | SUBSYS | SUBSYS |
0378-9119 | FENTANYL | FENTANYL |
0378-9121 | FENTANYL | FENTANYL |
0378-9122 | FENTANYL | FENTANYL |
0378-9123 | FENTANYL | FENTANYL |
0378-9124 | FENTANYL | FENTANYL |
0378-9125 | FENTANYL | FENTANYL |
0378-9126 | FENTANYL | FENTANYL |
0378-9127 | FENTANYL | FENTANYL |
0591-3198 | Fentanyl | Fentanyl |
0591-3212 | Fentanyl | Fentanyl |
0591-3213 | Fentanyl | Fentanyl |
0591-3214 | Fentanyl | Fentanyl |
0781-7240 | Fentanyl | Fentanyl |
0781-7241 | Fentanyl | Fentanyl |
0781-7242 | Fentanyl | Fentanyl |
0781-7243 | Fentanyl | Fentanyl |
0781-7244 | Fentanyl | Fentanyl |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUBSYS 85094244 4143369 Live/Registered |
INSYS DEVELOPMENT COMPANY, INC. 2010-07-27 |