| Product NDC: | 0378-7970 |
| Proprietary Name: | Ipratropium Bromide |
| Non Proprietary Name: | Ipratropium Bromide |
| Active Ingredient(s): | .5 mg/2.5mL & nbsp; Ipratropium Bromide |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0378-7970 |
| Labeler Name: | Mylan Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075693 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20101109 |
| Package NDC: | 0378-7970-55 |
| Package Description: | 30 POUCH in 1 CARTON (0378-7970-55) > 1 AMPULE in 1 POUCH (0378-7970-31) > 2.5 mL in 1 AMPULE |
| NDC Code | 0378-7970-55 |
| Proprietary Name | Ipratropium Bromide |
| Package Description | 30 POUCH in 1 CARTON (0378-7970-55) > 1 AMPULE in 1 POUCH (0378-7970-31) > 2.5 mL in 1 AMPULE |
| Product NDC | 0378-7970 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ipratropium Bromide |
| Dosage Form Name | SOLUTION |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20101109 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals, Inc. |
| Substance Name | IPRATROPIUM BROMIDE |
| Strength Number | .5 |
| Strength Unit | mg/2.5mL |
| Pharmaceutical Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |