Details for New Drug Application (NDA): 209235
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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 209235
Tradename: | IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | ibuprofen; pseudoephedrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 209235
Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 209235
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | ibuprofen; pseudoephedrine hydrochloride | CAPSULE;ORAL | 209235 | ANDA | WALGREEN CO. | 0363-1106 | 0363-1106-08 | 4 BLISTER PACK in 1 CARTON (0363-1106-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | ibuprofen; pseudoephedrine hydrochloride | CAPSULE;ORAL | 209235 | ANDA | WALGREEN CO. | 0363-1106 | 0363-1106-67 | 2 BLISTER PACK in 1 CARTON (0363-1106-67) / 10 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: | Dec 1, 2017 | TE: | RLD: | No |
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