Product NDC: | 20482-004 |
Proprietary Name: | SUBSYS |
Non Proprietary Name: | FENTANYL |
Active Ingredient(s): | .4 mg/1 & nbsp; FENTANYL |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | SPRAY |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 20482-004 |
Labeler Name: | Insys Therapeutics, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA202788 |
Marketing Category: | NDA |
Start Marketing Date: | 20120313 |
Package NDC: | 20482-004-10 |
Package Description: | 10 BLISTER PACK in 1 CARTON (20482-004-10) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY |
NDC Code | 20482-004-10 |
Proprietary Name | SUBSYS |
Package Description | 10 BLISTER PACK in 1 CARTON (20482-004-10) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY |
Product NDC | 20482-004 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | FENTANYL |
Dosage Form Name | SPRAY |
Route Name | SUBLINGUAL |
Start Marketing Date | 20120313 |
Marketing Category Name | NDA |
Labeler Name | Insys Therapeutics, Inc. |
Substance Name | FENTANYL |
Strength Number | .4 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |