Details for New Drug Application (NDA): 201803
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NDA 201803 describes ADVIL, which is a drug marketed by Haleon Us Holdings and is included in eleven NDAs. It is available from four suppliers. There are two patents 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. Thirty-one 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. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 201803
| Tradename: | ADVIL |
| Applicant: | Haleon Us Holdings |
| Ingredient: | ibuprofen sodium |
| Patents: | 0 |
Pharmacology for NDA: 201803
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 201803
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADVIL | ibuprofen sodium | TABLET;ORAL | 201803 | NDA | Haleon US Holdings LLC | 0573-0133 | 0573-0133-01 | 3000 PACKET in 1 CASE (0573-0133-01) / 2 TABLET, COATED in 1 PACKET |
| ADVIL | ibuprofen sodium | TABLET;ORAL | 201803 | NDA | Haleon US Holdings LLC | 0573-0133 | 0573-0133-02 | 50 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jun 12, 2012 | TE: | RLD: | Yes | |||||
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