Application 019872
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TYLENOL | ACETAMINOPHEN | TABLET, EXTENDED RELEASE;ORAL | 650MG | Yes | Yes |
| 002 | TYLENOL | ACETAMINOPHEN | TABLET, EXTENDED RELEASE;ORAL | 650MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50580-309 | Tylenol 8HR | acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-309 | Tylenol 8HR | acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-309 | Tylenol 8HR | acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-783 | Tylenol 8 HR Arthritis Pain | Acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-783 | Tylenol 8 HR Arthritis Pain | Acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-783 | Tylenol 8 HR Arthritis Pain | Acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-783 | Tylenol 8 HR Arthritis Pain | Acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-783 | Tylenol 8 HR Arthritis Pain | Acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-783 | Tylenol 8 HR Arthritis Pain | Acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |
| 50580-783 | Tylenol 8 HR Arthritis Pain | Acetaminophen | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | NDA | Current |