| Product NDC: | 60505-3573 |
| Proprietary Name: | Montelukast Sodium |
| Non Proprietary Name: | Montelukast Sodium |
| Active Ingredient(s): | 4 mg/1 & nbsp; Montelukast Sodium |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, CHEWABLE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 60505-3573 |
| Labeler Name: | Apotex Corp |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA201508 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120803 |
| Package NDC: | 60505-3573-8 |
| Package Description: | 1000 TABLET, CHEWABLE in 1 BOTTLE (60505-3573-8) |
| NDC Code | 60505-3573-8 |
| Proprietary Name | Montelukast Sodium |
| Package Description | 1000 TABLET, CHEWABLE in 1 BOTTLE (60505-3573-8) |
| Product NDC | 60505-3573 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Montelukast Sodium |
| Dosage Form Name | TABLET, CHEWABLE |
| Route Name | ORAL |
| Start Marketing Date | 20120803 |
| Marketing Category Name | ANDA |
| Labeler Name | Apotex Corp |
| Substance Name | MONTELUKAST SODIUM |
| Strength Number | 4 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |