Product NDC: | 68875-0101 |
Proprietary Name: | Gattex |
Non Proprietary Name: | teduglutide |
Active Ingredient(s): | 5 mg/1 & nbsp; teduglutide |
Administration Route(s): | SUBCUTANEOUS |
Dosage Form(s): | INJECTION, POWDER, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68875-0101 |
Labeler Name: | NPS Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA203441 |
Marketing Category: | NDA |
Start Marketing Date: | 20121221 |
Package NDC: | 68875-0101-2 |
Package Description: | 30 VIAL in 1 CARTON (68875-0101-2) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (68875-0101-1) |
NDC Code | 68875-0101-2 |
Proprietary Name | Gattex |
Package Description | 30 VIAL in 1 CARTON (68875-0101-2) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (68875-0101-1) |
Product NDC | 68875-0101 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | teduglutide |
Dosage Form Name | INJECTION, POWDER, FOR SOLUTION |
Route Name | SUBCUTANEOUS |
Start Marketing Date | 20121221 |
Marketing Category Name | NDA |
Labeler Name | NPS Pharmaceuticals |
Substance Name | TEDUGLUTIDE |
Strength Number | 5 |
Strength Unit | mg/1 |
Pharmaceutical Classes |