Application 213794
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-5432 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5432 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5433 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5433 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5433 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5435 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5435 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5435 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5435 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5438 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5444 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5444 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5445 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5445 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5445 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5446 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5446 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5446 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5446 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-5446 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 59651-360 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-360 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-360 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-360 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-361 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-361 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-361 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-361 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-362 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-362 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-362 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 59651-362 | Ibuprofen | Ibuprofen | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2860 | Ibuprofen | Ibuprofen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2903 | Ibuprofen | Ibuprofen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8319 | Ibuprofen | Ibuprofen | Preferred Pharmaceuticals Inc. | ANDA | Current |