Details for New Drug Application (NDA): 211733
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NDA 211733 describes ADVIL DUAL ACTION WITH ACETAMINOPHEN, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from three suppliers. Additional details are available on the ADVIL DUAL ACTION WITH ACETAMINOPHEN profile page.
The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-five 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: | 0 |
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 | |||||
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