Application 203366
- 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;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-102 | Montelukast | Montelukast | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-102 | Montelukast | Montelukast | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-102 | Montelukast | Montelukast | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-102 | Montelukast | Montelukast | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-102 | Montelukast | Montelukast | Macleods Pharmaceuticals Limited | ANDA | Current |
| 68001-361 | Montelukast | Montelukast | BluePoint Laboratories | ANDA | Current |
| 68001-361 | Montelukast | Montelukast | BluePoint Laboratories | ANDA | Current |
| 68001-361 | Montelukast | Montelukast | BluePoint Laboratories | ANDA | Current |
| 68001-361 | Montelukast | Montelukast | BluePoint Laboratories | ANDA | Current |
| 68001-361 | Montelukast | Montelukast | BluePoint Laboratories | ANDA | Current |
| 68001-361 | Montelukast | Montelukast | BluePoint Laboratories | ANDA | Current |
| 68071-4034 | Montelukast | Montelukast | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4034 | Montelukast | Montelukast | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-1031 | Montelukast | Montelukast | REMEDYREPACK INC. | ANDA | Current |
| 70518-1031 | Montelukast | Montelukast | REMEDYREPACK INC. | ANDA | Current |
| 70518-2603 | Montelukast | Montelukast | REMEDYREPACK INC. | ANDA | Current |
| 70518-2603 | Montelukast | Montelukast | REMEDYREPACK INC. | ANDA | Current |
| 70518-2603 | Montelukast | Montelukast | REMEDYREPACK INC. | ANDA | Current |