Application 081034
- Type
- ANDA
- Sponsor
- AUXILIUM PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THEO-24 | THEOPHYLLINE | CAPSULE, EXTENDED RELEASE;ORAL | 400MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52244-400 | Theo-24 | theophylline anhydrous | Endo Pharmaceuticals, Inc. | ANDA | Current |