Product NDC: | 61938-456 |
Proprietary Name: | INFASURF |
Non Proprietary Name: | CALFACTANT |
Active Ingredient(s): | 35.7 mg/mL & nbsp; CALFACTANT |
Administration Route(s): | ENDOTRACHEAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 61938-456 |
Labeler Name: | Ony, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020521 |
Marketing Category: | NDA |
Start Marketing Date: | 20110721 |
Package NDC: | 61938-456-06 |
Package Description: | 1 VIAL, GLASS in 1 CARTON (61938-456-06) > 6 mL in 1 VIAL, GLASS |
NDC Code | 61938-456-06 |
Proprietary Name | INFASURF |
Package Description | 1 VIAL, GLASS in 1 CARTON (61938-456-06) > 6 mL in 1 VIAL, GLASS |
Product NDC | 61938-456 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | CALFACTANT |
Dosage Form Name | SUSPENSION |
Route Name | ENDOTRACHEAL |
Start Marketing Date | 20110721 |
Marketing Category Name | NDA |
Labeler Name | Ony, Inc. |
Substance Name | CALFACTANT |
Strength Number | 35.7 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] |