Details for New Drug Application (NDA): 211733
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The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 211733
| Tradename: | ADVIL DUAL ACTION WITH ACETAMINOPHEN |
| Applicant: | Haleon Us Holdings |
| Ingredient: | acetaminophen; ibuprofen |
| Patents: | 1 |
Pharmacology for NDA: 211733
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 211733
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen; ibuprofen | TABLET;ORAL | 211733 | NDA | Haleon US Holdings LLC | 0573-0145 | 0573-0145-02 | 2 TABLET, FILM COATED in 1 POUCH (0573-0145-02) |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | acetaminophen; ibuprofen | TABLET;ORAL | 211733 | NDA | Haleon US Holdings LLC | 0573-0145 | 0573-0145-18 | 1 BOTTLE in 1 CARTON (0573-0145-18) / 18 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 250MG;125MG | ||||
| Approval Date: | Feb 28, 2020 | TE: | RLD: | Yes | |||||
| Patent: | 11,918,693 | Patent Expiration: | Jul 9, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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