Details for New Drug Application (NDA): 021374
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The generic ingredient in ADVIL COLD AND SINUS is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.
Summary for 021374
Tradename: | ADVIL COLD AND SINUS |
Applicant: | Haleon Us Holdings |
Ingredient: | ibuprofen; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021374
Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 021374
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ADVIL COLD AND SINUS | ibuprofen; pseudoephedrine hydrochloride | CAPSULE;ORAL | 021374 | NDA | Haleon US Holdings LLC | 0573-0184 | 0573-0184-16 | 16 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
ADVIL COLD AND SINUS | ibuprofen; pseudoephedrine hydrochloride | CAPSULE;ORAL | 021374 | NDA | Haleon US Holdings LLC | 0573-0184 | 0573-0184-32 | 32 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | ||||
Approval Date: | May 30, 2002 | TE: | RLD: | Yes |
Expired US Patents for NDA 021374
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Haleon Us Holdings | ADVIL COLD AND SINUS | ibuprofen; pseudoephedrine hydrochloride | CAPSULE;ORAL | 021374-001 | May 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Haleon Us Holdings | ADVIL COLD AND SINUS | ibuprofen; pseudoephedrine hydrochloride | CAPSULE;ORAL | 021374-001 | May 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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