Details for New Drug Application (NDA): 018989
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NDA 018989 describes ADVIL, which is a drug marketed by Haleon Us Holdings and is included in eleven NDAs. It is available from four suppliers. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the ADVIL profile page.
The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 018989
| Tradename: | ADVIL |
| Applicant: | Haleon Us Holdings |
| Ingredient: | ibuprofen |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018989
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 018989
Suppliers and Packaging for NDA: 018989
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADVIL | ibuprofen | TABLET;ORAL | 018989 | NDA | Haleon US Holdings LLC | 0573-0150 | 0573-0150-20 | 1 BOTTLE in 1 CARTON (0573-0150-20) / 24 TABLET, COATED in 1 BOTTLE |
| ADVIL | ibuprofen | TABLET;ORAL | 018989 | NDA | Haleon US Holdings LLC | 0573-0150 | 0573-0150-30 | 1 BOTTLE in 1 CARTON (0573-0150-30) / 50 TABLET, COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 18, 1984 | TE: | RLD: | Yes | |||||
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