Application 203795
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-358 | Montelukast sodium chewable | montelukast sodium | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-358 | Montelukast sodium chewable | montelukast sodium | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-359 | Montelukast sodium chewable | montelukast sodium | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-359 | Montelukast sodium chewable | montelukast sodium | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |