Application 209179
- 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 |
|---|
| 10202-150 | CHILDRENS IBUPROFEN | Ibuprofen | 7-Eleven | ANDA | Current |
| 10202-711 | CHILDRENS IBUPROFEN | Ibuprofen | 7-Eleven | ANDA | Current |
| 10202-711 | CHILDRENS IBUPROFEN | Ibuprofen | 7-Eleven | ANDA | Current |
| 10202-711 | CHILDRENS IBUPROFEN | Ibuprofen | 7-Eleven | ANDA | Current |
| 10202-711 | CHILDRENS IBUPROFEN | Ibuprofen | 7-Eleven | ANDA | Current |
| 58602-002 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-002 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-003 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-008 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-200 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-200 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-200 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-200 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-200 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-212 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-212 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-212 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 58602-212 | CHILDRENS IBUPROFEN | Ibuprofen | Aurohealth LLC | ANDA | Current |
| 68001-435 | CHILDRENS IBUPROFEN | Ibuprofen | BluePoint Laboratories | ANDA | Current |
| 68001-435 | CHILDRENS IBUPROFEN | Ibuprofen | BluePoint Laboratories | ANDA | Current |
| 68001-521 | CHILDRENS IBUPROFEN | Ibuprofen | BluePoint Laboratories | ANDA | Current |
| 79395-003 | CHILDRENS IBUPROFEN | Ibuprofen | Chalkboard Health | ANDA | Current |
| 79395-003 | CHILDRENS IBUPROFEN | Ibuprofen | Chalkboard Health | ANDA | Current |
| 79395-003 | CHILDRENS IBUPROFEN | Ibuprofen | Chalkboard Health | ANDA | Current |