Application 215318
- Type
- ANDA
- Sponsor
- YICHANG HUMANWELL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 400MG | No | No |
| 002 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 600MG | No | No |
| 003 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70436-180 | Ibuprofen | Ibuprofen | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-180 | Ibuprofen | Ibuprofen | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-181 | Ibuprofen | Ibuprofen | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-181 | Ibuprofen | Ibuprofen | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-182 | Ibuprofen | Ibuprofen | Slate Run Pharmaceuticals, LLC | ANDA | Current |
| 70436-182 | Ibuprofen | Ibuprofen | Slate Run Pharmaceuticals, LLC | ANDA | Current |