Application 201582
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 55111-725 | Montelukast Sodium | Montelukast Sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-725 | Montelukast Sodium | Montelukast Sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-725 | Montelukast Sodium | Montelukast Sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-725 | Montelukast Sodium | Montelukast Sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-725 | Montelukast Sodium | Montelukast Sodium | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 68084-875 | Montelukast Sodium | Montelukast Sodium | American Health Packaging | ANDA | Current |
| 68084-875 | Montelukast Sodium | Montelukast Sodium | American Health Packaging | ANDA | Current |
| 68084-875 | Montelukast Sodium | Montelukast Sodium | American Health Packaging | ANDA | Current |
| 68084-875 | Montelukast Sodium | Montelukast Sodium | American Health Packaging | ANDA | Current |
| 68084-875 | Montelukast Sodium | Montelukast Sodium | American Health Packaging | ANDA | Current |
| 68645-466 | Montelukast Sodium | Montelukast Sodium | Legacy Pharmaceutical Pac | ANDA | Current |
| 70518-1085 | Montelukast Sodium | Montelukast Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1085 | Montelukast Sodium | Montelukast Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1784 | Montelukast Sodium | Montelukast Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1784 | Montelukast Sodium | Montelukast Sodium | REMEDYREPACK INC. | ANDA | Current |