Application 090984
- 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, CHEWABLE;ORAL | EQ 4MG BASE | No | No |
| 002 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-079 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-080 | Montelukast Sodium | Montelukast Sodium | Torrent Pharmaceuticals Limited | ANDA | Current |
| 43063-381 | Montelukast Sodium | Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-381 | Montelukast Sodium | Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-381 | Montelukast Sodium | Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-381 | Montelukast Sodium | Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-381 | Montelukast Sodium | Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-381 | Montelukast Sodium | Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-381 | Montelukast Sodium | Montelukast Sodium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 61919-097 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | DIRECT RX | ANDA | Current |
| 61919-097 | MONTELUKAST SODIUM | MONTELUKAST SODIUM | DIRECT RX | ANDA | Current |
| 63187-550 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
| 63187-550 | Montelukast Sodium | Montelukast Sodium | Proficient Rx LP | ANDA | Current |
| 68071-1755 | Montelukast Sodium | Montelukast Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1755 | Montelukast Sodium | Montelukast Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4054 | Montelukast Sodium | Montelukast Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5141 | Montelukast Sodium | Montelukast Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5141 | Montelukast Sodium | Montelukast Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6946 | Montelukast Sodium | Montelukast Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6946 | Montelukast Sodium | Montelukast Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6946 | Montelukast Sodium | Montelukast Sodium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7064 | Montelukast Sodium | Montelukast Sodium | {Preferred Pharmaeutials INC. | ANDA | Current |
| 68788-7064 | Montelukast Sodium | Montelukast Sodium | {Preferred Pharmaeutials INC. | ANDA | Current |
| 68788-7064 | Montelukast Sodium | Montelukast Sodium | {Preferred Pharmaeutials INC. | ANDA | Current |
| 71335-0301 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0301 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0620 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0620 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1326 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1326 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1326 | Montelukast Sodium | Montelukast Sodium | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31510 | ORIG | 2012-08-07 |