Application 201515
- Type
- ANDA
- Sponsor
- TORRENT PHARMS 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 |
|---|
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-081 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 63187-430 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
| 63187-430 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
| 71335-0374 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9898 | ORIG | 2012-08-07 |