Application 203582
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | No | No |
| 002 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-110 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-110 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-110 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-110 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-111 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-111 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-111 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-111 | Montelukast sodium | Montelukast sodium | Macleods Pharmaceuticals Limited | ANDA | Current |