Application 091586
- Type
- ANDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THEOPHYLLINE | THEOPHYLLINE | SOLUTION;ORAL | 80MG/15ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17856-0038 | Theophylline | Theophylline | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-0038 | Theophylline | Theophylline | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 27808-033 | Theophylline | Theophylline | Tris Pharma Inc | ANDA | Current |
| 27808-033 | Theophylline | Theophylline | Tris Pharma Inc | ANDA | Current |
| 27808-033 | Theophylline | Theophylline | Tris Pharma Inc | ANDA | Current |
| 60621-033 | Theophylline | Theophylline Anhydrous | Cranbury Pharmaceuticals Inc | ANDA | Current |