Details for New Drug Application (NDA): 022113
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NDA 022113 describes ADVIL MULTI-SYMPTOM COLD & FLU, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from two suppliers. Additional details are available on the ADVIL MULTI-SYMPTOM COLD & FLU profile page.
The generic ingredient in ADVIL MULTI-SYMPTOM COLD & FLU is chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride profile page.
The generic ingredient in ADVIL MULTI-SYMPTOM COLD & FLU is chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride profile page.
Summary for 022113
| Tradename: | ADVIL MULTI-SYMPTOM COLD & FLU |
| Applicant: | Haleon Us Holdings |
| Ingredient: | chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 022113
| Mechanism of Action | Adrenergic alpha1-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 022113
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADVIL ALLERGY AND CONGESTION RELIEF | chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride | TABLET;ORAL | 022113 | NDA | Haleon US Holdings LLC | 0573-0190 | 0573-0190-01 | 50 POUCH in 1 TRAY (0573-0190-01) / 1 TABLET, COATED in 1 POUCH |
| ADVIL ALLERGY AND CONGESTION RELIEF | chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride | TABLET;ORAL | 022113 | NDA | Haleon US Holdings LLC | 0573-0190 | 0573-0190-02 | 2 POUCH in 1 CARTON (0573-0190-02) / 1 TABLET, COATED in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 4MG;200MG;10MG | ||||
| Approval Date: | Dec 21, 2011 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 4MG;200MG;10MG | ||||
| Approval Date: | Apr 28, 2017 | TE: | RLD: | Yes | |||||
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