Product NDC: | 0378-6040 |
Proprietary Name: | Montelukast Sodium |
Non Proprietary Name: | montelukast |
Active Ingredient(s): | 4 mg/1 & nbsp; montelukast |
Administration Route(s): | ORAL |
Dosage Form(s): | GRANULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-6040 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA202776 |
Marketing Category: | ANDA |
Start Marketing Date: | 20121219 |
Package NDC: | 0378-6040-93 |
Package Description: | 30 GRANULE in 1 CARTON (0378-6040-93) |
NDC Code | 0378-6040-93 |
Proprietary Name | Montelukast Sodium |
Package Description | 30 GRANULE in 1 CARTON (0378-6040-93) |
Product NDC | 0378-6040 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | montelukast |
Dosage Form Name | GRANULE |
Route Name | ORAL |
Start Marketing Date | 20121219 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | MONTELUKAST SODIUM |
Strength Number | 4 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |