Product NDC: | 0362-0101 |
Proprietary Name: | Oraverse |
Non Proprietary Name: | Phentolamine Mesylate |
Active Ingredient(s): | .235 mg/mL & nbsp; Phentolamine Mesylate |
Administration Route(s): | SUBMUCOSAL |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0362-0101 |
Labeler Name: | Septodont, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022159 |
Marketing Category: | NDA |
Start Marketing Date: | 20110601 |
Package NDC: | 0362-0101-10 |
Package Description: | 10 CARTRIDGE in 1 CARTON (0362-0101-10) > 1.7 mL in 1 CARTRIDGE |
NDC Code | 0362-0101-10 |
Proprietary Name | Oraverse |
Package Description | 10 CARTRIDGE in 1 CARTON (0362-0101-10) > 1.7 mL in 1 CARTRIDGE |
Product NDC | 0362-0101 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Phentolamine Mesylate |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | SUBMUCOSAL |
Start Marketing Date | 20110601 |
Marketing Category Name | NDA |
Labeler Name | Septodont, Inc. |
Substance Name | PHENTOLAMINE MESYLATE |
Strength Number | .235 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] |