Application 019012
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NUPRIN | IBUPROFEN | TABLET;ORAL | 200MG | No | No |
| 002 | NUPRIN | IBUPROFEN | TABLET;ORAL | 200MG | No | No |
| 003 | MOTRIN IB | IBUPROFEN | TABLET;ORAL | 200MG | Yes | No |
| 004 | MOTRIN MIGRAINE PAIN | IBUPROFEN | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 29485-1465 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 29485-1465 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 29485-1465 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 29485-1465 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 29485-7006 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 29485-7006 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 29485-7938 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 29485-7938 | Motrin IB | Ibuprofen | Mechanical Servants, LLC | NDA | Current |
| 50580-110 | Motrin IB | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-110 | Motrin IB | Ibuprofen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 66715-9712 | Motrin IB | Ibuprofen | Lil' Drug Store Products, Inc. | NDA | Current |
| 67751-165 | Motrin IB | IBUPROFEN | Navajo Manufacturing Company Inc. | NDA | Current |
| 67751-165 | Motrin IB | IBUPROFEN | Navajo Manufacturing Company Inc. | NDA | Current |
| 73097-008 | Motrin IB | IBUPROFEN | Savings Distributors LLC | NDA | Current |