Details for New Drug Application (NDA): 219962
NDA 219962 describes TYLENOL WITH NAPROXEN, which is a drug marketed by Kenvue Brands and is included in one NDA. Additional details are available on the TYLENOL WITH NAPROXEN profile page.
The generic ingredient in TYLENOL WITH NAPROXEN is acetaminophen; naproxen sodium. There is one drug master file entry for this compound. Additional details are available on the acetaminophen; naproxen sodium profile page.
The generic ingredient in TYLENOL WITH NAPROXEN is acetaminophen; naproxen sodium. There is one drug master file entry for this compound. Additional details are available on the acetaminophen; naproxen sodium profile page.
Summary for 219962
| Tradename: | TYLENOL WITH NAPROXEN |
| Applicant: | Kenvue Brands |
| Ingredient: | acetaminophen; naproxen sodium |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219962
Generic Entry Date for 219962*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 325MG;110MG | ||||
| Approval Date: | Jul 24, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 24, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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