| Product NDC: | 51772-314 |
| Proprietary Name: | LAZANDA |
| Non Proprietary Name: | Fentanyl Citrate |
| Active Ingredient(s): | 400 ug/1 & nbsp; Fentanyl Citrate |
| Administration Route(s): | NASAL |
| Dosage Form(s): | SPRAY |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 51772-314 |
| Labeler Name: | Archimedes Pharma US Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022569 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20111017 |
| Package NDC: | 51772-314-01 |
| Package Description: | 1 BOTTLE, SPRAY in 1 CARTON (51772-314-01) > 8 SPRAY in 1 BOTTLE, SPRAY |
| NDC Code | 51772-314-01 |
| Proprietary Name | LAZANDA |
| Package Description | 1 BOTTLE, SPRAY in 1 CARTON (51772-314-01) > 8 SPRAY in 1 BOTTLE, SPRAY |
| Product NDC | 51772-314 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Fentanyl Citrate |
| Dosage Form Name | SPRAY |
| Route Name | NASAL |
| Start Marketing Date | 20111017 |
| Marketing Category Name | NDA |
| Labeler Name | Archimedes Pharma US Inc. |
| Substance Name | FENTANYL CITRATE |
| Strength Number | 400 |
| Strength Unit | ug/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |