Product NDC: | 0054-0259 |
Proprietary Name: | Montelukast Sodium |
Non Proprietary Name: | Montelukast Sodium |
Active Ingredient(s): | 10 mg/1 & nbsp; Montelukast Sodium |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0054-0259 |
Labeler Name: | Roxane Laboratories, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA090655 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120803 |
Package NDC: | 0054-0259-22 |
Package Description: | 90 TABLET in 1 BOTTLE (0054-0259-22) |
NDC Code | 0054-0259-22 |
Proprietary Name | Montelukast Sodium |
Package Description | 90 TABLET in 1 BOTTLE (0054-0259-22) |
Product NDC | 0054-0259 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Montelukast Sodium |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20120803 |
Marketing Category Name | ANDA |
Labeler Name | Roxane Laboratories, Inc. |
Substance Name | MONTELUKAST SODIUM |
Strength Number | 10 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |