Application 213471
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | GRANULE;ORAL | EQ 4MG BASE/PACKET | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-329 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-329 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-329 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-329 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-329 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-329 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 59651-329 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |