Application 091576
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS LLC
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 |
|---|
| 0603-4655 | Montelukast Sodium | Montelukast Sodium | Par Pharmaceutical | ANDA | Current |
| 0603-4655 | Montelukast Sodium | Montelukast Sodium | Par Pharmaceutical | ANDA | Current |
| 0904-6529 | Montelukast Sodium | Montelukast Sodium | Major Pharmaceuticals | ANDA | Current |
| 53808-0690 | Montelukast Sodium | Montelukast Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0995 | Montelukast Sodium | Montelukast Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-7638 | Montelukast Sodium | Montelukast Sodium | Cardinal Health | ANDA | Current |
| 55154-7638 | Montelukast Sodium | Montelukast Sodium | Cardinal Health | ANDA | Current |
| 64205-655 | Montelukast Sodium | Montelukast Sodium | ReadyMeds | ANDA | Current |
| 68151-3494 | Montelukast Sodium | Montelukast Sodium | Carilion Materials Management | ANDA | Current |
| 68151-3498 | Montelukast Sodium | Montelukast Sodium | Carilion Materials Management | ANDA | Current |
| 70518-0805 | Montelukast Sodium | Montelukast Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0805 | Montelukast Sodium | Montelukast Sodium | REMEDYREPACK INC. | ANDA | Current |
| 71610-051 | Montelukast Sodium | Montelukast Sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31538 | ORIG | 2012-08-06 |