Application 090355
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
| 002 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 600MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-356 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-356 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-356 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-380 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-380 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-380 | Theophylline | Theophylline | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |