Product NDC: | 0378-4124 |
Proprietary Name: | Albuterol Sulfate |
Non Proprietary Name: | albuterol sulfate |
Active Ingredient(s): | 8 mg/1 & nbsp; albuterol sulfate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-4124 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078092 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120214 |
Package NDC: | 0378-4124-01 |
Package Description: | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4124-01) |
NDC Code | 0378-4124-01 |
Proprietary Name | Albuterol Sulfate |
Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4124-01) |
Product NDC | 0378-4124 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | albuterol sulfate |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20120214 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | ALBUTEROL SULFATE |
Strength Number | 8 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] |