Application 087943
- Type
- ANDA
- Sponsor
- AUXILIUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | THEO-24 | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 200MG | No | No |
| 002 | THEO-24 | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
| 003 | THEO-24 | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 004 | THEO-24 | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 400MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 52244-200 | Theo-24 | theophylline anhydrous | Endo Pharmaceuticals, Inc. | ANDA | Current |