Application 040086
- Type
- ANDA
- Sponsor
- RHODES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 600MG | No | No |
| 002 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42858-701 | Theophylline | Theophylline | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-701 | Theophylline | Theophylline | Rhodes Pharmaceuticals | ANDA | Current |
| 42858-702 | Theophylline | Theophylline | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-702 | Theophylline | Theophylline | Rhodes Pharmaceuticals L.P. | ANDA | Current |
| 42858-702 | Theophylline | Theophylline | Rhodes Pharmaceuticals | ANDA | Current |
| 67781-252 | Uniphyl | theophylline anhydrous | Purdue Pharmaceutical Products LP | ANDA | Current |