NDC Code | 0378-4124-05 |
Package Description | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4124-05) |
Product NDC | 0378-4124 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Albuterol Sulfate |
Non-Proprietary Name | Albuterol Sulfate |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20070130 |
Marketing Category Name | ANDA |
Application Number | ANDA078092 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | ALBUTEROL SULFATE |
Strength | 8 |
Strength Unit | mg/1 |
Pharmacy Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |