Details for New Drug Application (NDA): 021441
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NDA 021441 describes ADVIL ALLERGY SINUS, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ADVIL ALLERGY SINUS profile page.
The generic ingredient in ADVIL ALLERGY SINUS is chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride profile page.
The generic ingredient in ADVIL ALLERGY SINUS is chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride profile page.
Summary for 021441
| Tradename: | ADVIL ALLERGY SINUS |
| Applicant: | Haleon Us Holdings |
| Ingredient: | chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021441
Generic Entry Date for 021441*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 021441
| Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 021441
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADVIL ALLERGY SINUS | chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 021441 | NDA | Haleon US Holdings LLC | 0573-0188 | 0573-0188-10 | 20 BLISTER PACK in 1 CARTON (0573-0188-10) / 1 TABLET, COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG;200MG;30MG | ||||
| Approval Date: | Dec 19, 2002 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 28, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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