Application 202468
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| 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 | Labeler | Marketing category | Status |
|---|
| 52343-037 | Montelukast Sodium | Montelukast Sodium | ACETRIS HEALTH, LLC | ANDA | Current |
| 52343-037 | Montelukast Sodium | Montelukast Sodium | ACETRIS HEALTH, LLC | ANDA | Current |
| 53808-0920 | Montelukast Sodium | Montelukast Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 57237-255 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-255 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-255 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-255 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 57237-255 | Montelukast Sodium | Montelukast Sodium | Rising Health, LLC | ANDA | Current |
| 65862-574 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-574 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-574 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-574 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-574 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-574 | Montelukast Sodium | Montelukast Sodium | Aurobindo Pharma Limited | ANDA | Current |
| 71610-129 | Montelukast Sodium | Montelukast Sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 10057 | ORIG | 2012-08-06 |