Product NDC: | 10122-510 |
Proprietary Name: | Curosurf |
Non Proprietary Name: | poractant alfa |
Active Ingredient(s): | 80 mg/mL & nbsp; poractant alfa |
Administration Route(s): | ENDOTRACHEAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 10122-510 |
Labeler Name: | Cornerstone Therapeutics Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020744 |
Marketing Category: | NDA |
Start Marketing Date: | 19991118 |
Package NDC: | 10122-510-03 |
Package Description: | 3 mL in 1 VIAL, GLASS (10122-510-03) |
NDC Code | 10122-510-03 |
Proprietary Name | Curosurf |
Package Description | 3 mL in 1 VIAL, GLASS (10122-510-03) |
Product NDC | 10122-510 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | poractant alfa |
Dosage Form Name | SUSPENSION |
Route Name | ENDOTRACHEAL |
Start Marketing Date | 19991118 |
Marketing Category Name | NDA |
Labeler Name | Cornerstone Therapeutics Inc. |
Substance Name | PORACTANT ALFA |
Strength Number | 80 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] |