Product NDC: | 42747-224 |
Proprietary Name: | Abstral |
Non Proprietary Name: | fentanyl |
Active Ingredient(s): | 400 ug/1 & nbsp; fentanyl |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 42747-224 |
Labeler Name: | ProStrakan, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022510 |
Marketing Category: | NDA |
Start Marketing Date: | 20110107 |
Package NDC: | 42747-224-32 |
Package Description: | 32 TABLET in 1 BLISTER PACK (42747-224-32) |
NDC Code | 42747-224-32 |
Proprietary Name | Abstral |
Package Description | 32 TABLET in 1 BLISTER PACK (42747-224-32) |
Product NDC | 42747-224 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | fentanyl |
Dosage Form Name | TABLET |
Route Name | SUBLINGUAL |
Start Marketing Date | 20110107 |
Marketing Category Name | NDA |
Labeler Name | ProStrakan, Inc. |
Substance Name | FENTANYL CITRATE |
Strength Number | 400 |
Strength Unit | ug/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |