Product NDC: | 0781-5554 |
Proprietary Name: | Montelukast |
Non Proprietary Name: | Montelukast |
Active Ingredient(s): | 4 mg/1 & nbsp; Montelukast |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, CHEWABLE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0781-5554 |
Labeler Name: | Sandoz Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091414 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120803 |
Package NDC: | 0781-5554-31 |
Package Description: | 30 TABLET, CHEWABLE in 1 BOTTLE (0781-5554-31) |
NDC Code | 0781-5554-31 |
Proprietary Name | Montelukast |
Package Description | 30 TABLET, CHEWABLE in 1 BOTTLE (0781-5554-31) |
Product NDC | 0781-5554 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Montelukast |
Dosage Form Name | TABLET, CHEWABLE |
Route Name | ORAL |
Start Marketing Date | 20120803 |
Marketing Category Name | ANDA |
Labeler Name | Sandoz Inc |
Substance Name | MONTELUKAST SODIUM |
Strength Number | 4 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] |