| Product NDC: | 0456-0800 |
| Proprietary Name: | Tudorza Pressair |
| Non Proprietary Name: | aclidinium bromide |
| Active Ingredient(s): | 400 ug/1 & nbsp; aclidinium bromide |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | INHALANT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0456-0800 |
| Labeler Name: | Forest Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202450 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120723 |
| Package NDC: | 0456-0800-31 |
| Package Description: | 1 POUCH in 1 CARTON (0456-0800-31) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER |
| NDC Code | 0456-0800-31 |
| Proprietary Name | Tudorza Pressair |
| Package Description | 1 POUCH in 1 CARTON (0456-0800-31) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER |
| Product NDC | 0456-0800 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | aclidinium bromide |
| Dosage Form Name | INHALANT |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20120723 |
| Marketing Category Name | NDA |
| Labeler Name | Forest Laboratories, Inc. |
| Substance Name | ACLIDINIUM BROMIDE |
| Strength Number | 400 |
| Strength Unit | ug/1 |
| Pharmaceutical Classes |