Details for New Drug Application (NDA): 213565
NDA 213565 describes IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Perrigo, Aurobindo Pharma Ltd, Contract Pharmacal, and Strides Pharma, and is included in five NDAs. It is available from five suppliers. Additional details are available on the IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.
The generic ingredient in IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE is ibuprofen; pseudoephedrine hydrochloride. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.
The generic ingredient in IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE is ibuprofen; pseudoephedrine hydrochloride. There is one drug master file entry for this compound. Ten 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: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG;30MG | ||||
| Approval Date: | Mar 10, 2023 | TE: | RLD: | No | |||||
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