Application 209178
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |
| 59651-032 | Ibuprofen | Ibuprofen Oral | Aurobindo Pharma Limited | ANDA | Current |