Application 090926
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 33261-969 | montelukast sodium | montelukast sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 68001-248 | montelukast sodium | montelukast sodium | BluePoint Laboratories | ANDA | Current |
| 68001-248 | montelukast sodium | montelukast sodium | BluePoint Laboratories | ANDA | Current |
| 68462-392 | montelukast sodium | montelukast sodium | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9306 | ORIG | 2012-08-06 |