Application 202859
- Type
- ANDA
- Sponsor
- UNIMARK REMEDIES 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 |
|---|
| 0143-9649 | MONTELUKAST | MONTELUKAST | West ward Pharmaceutical Corp | ANDA | Current |
| 51128-501 | MONTELUKAST | MONTELUKAST | Recipharm Pharmaservices Private Limited | ANDA | Current |
| 51128-501 | MONTELUKAST | MONTELUKAST | Recipharm Pharmaservices Private Limited | ANDA | Current |
| 68071-1652 | MONTELUKAST | MONTELUKAST | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 69452-105 | MONTELUKAST | MONTELUKAST | Bionpharma Inc. | ANDA | Current |
| 69452-105 | MONTELUKAST | MONTELUKAST | Bionpharma Inc. | ANDA | Current |
| 69452-105 | MONTELUKAST | MONTELUKAST | Bionpharma Inc. | ANDA | Current |