Application 020516
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CHILDREN'S MOTRIN | IBUPROFEN | SUSPENSION;ORAL | 100MG/5ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 44237-041 | Childrens Novex Ibuprofen | Ibuprofen | Herbion Pakistan (Pvt.) Ltd | NDA | Current |
| 50580-184 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-184 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-184 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-184 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-184 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-601 | Childrens MOTRIN | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-601 | Childrens MOTRIN | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-601 | Childrens MOTRIN | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-601 | Childrens MOTRIN | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-601 | Childrens MOTRIN | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-603 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-603 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-603 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-604 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-604 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-604 | Childrens Motrin | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 78307-100 | Childrens Novufen Ibuprofen | Ibuprofen | NOVUGEN PHARMA LLC | NDA | Current |