Application 205647
- Type
- ANDA
- Sponsor
- HI TECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50383-584 | Ibuprofen | Ibuprofen | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-584 | Ibuprofen | Ibuprofen | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-584 | Ibuprofen | Ibuprofen | Akorn | ANDA | Current |
| 50383-584 | Ibuprofen | Ibuprofen | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 55154-9628 | Ibuprofen | Ibuprofen | Cardinal Health | ANDA | Current |