Application 089763
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THEOPHYLLINE | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-1590 | Theophylline Extended Release | Theophylline, anhydrous | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 23155-741 | Theophylline | Theophylline | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 50111-459 | Theophylline | Theophylline | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 53808-0316 | Theophylline | Theophylline | State of Florida DOH Central Pharmacy | ANDA | Current |
| 63629-5198 | Theophylline | Theophylline | Bryant Ranch Prepack | ANDA | Current |