Details for New Drug Application (NDA): 213565
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The generic ingredient in IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE 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 213565
Tradename: | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | ibuprofen; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213565
Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 213565
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 213565 | ANDA | Aurohealth LLC | 58602-839 | 58602-839-13 | 4 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG;30MG | ||||
Approval Date: | Mar 10, 2023 | TE: | RLD: | No |
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