| Product NDC: | 0268-0609 |
| Proprietary Name: | COTTON FIBER |
| Non Proprietary Name: | COTTON LINTERS |
| Active Ingredient(s): | .05 g/mL & nbsp; COTTON LINTERS |
| Administration Route(s): | SUBCUTANEOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0268-0609 |
| Labeler Name: | ALK-Abello, Inc. |
| Product Type: | NON-STANDARDIZED ALLERGENIC |
| FDA Application Number: | BLA103753 |
| Marketing Category: | BLA |
| Start Marketing Date: | 19650101 |
| Package NDC: | 0268-0609-50 |
| Package Description: | 50 mL in 1 VIAL, MULTI-DOSE (0268-0609-50) |
| NDC Code | 0268-0609-50 |
| Proprietary Name | COTTON FIBER |
| Package Description | 50 mL in 1 VIAL, MULTI-DOSE (0268-0609-50) |
| Product NDC | 0268-0609 |
| Product Type Name | NON-STANDARDIZED ALLERGENIC |
| Non Proprietary Name | COTTON LINTERS |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | SUBCUTANEOUS |
| Start Marketing Date | 19650101 |
| Marketing Category Name | BLA |
| Labeler Name | ALK-Abello, Inc. |
| Substance Name | COTTON FIBER |
| Strength Number | .05 |
| Strength Unit | g/mL |
| Pharmaceutical Classes | Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] |