Details for New Drug Application (NDA): 074567
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NDA 074567 describes IBUPROHM COLD AND SINUS, which is a drug marketed by Ohm Labs and is included in one NDA. It is available from eight suppliers. Additional details are available on the IBUPROHM COLD AND SINUS profile page.
The generic ingredient in IBUPROHM 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.
The generic ingredient in IBUPROHM 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 074567
| Tradename: | IBUPROHM COLD AND SINUS |
| Applicant: | Ohm Labs |
| Ingredient: | ibuprofen; pseudoephedrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 074567
| Mechanism of Action | Adrenergic alpha-Agonists Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 074567
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROHM COLD AND SINUS | ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 074567 | ANDA | WALGREEN COMPANY | 0363-0423 | 0363-0423-21 | 20 TABLET, COATED in 1 BLISTER PACK (0363-0423-21) |
| IBUPROHM COLD AND SINUS | ibuprofen; pseudoephedrine hydrochloride | TABLET;ORAL | 074567 | ANDA | WALGREEN COMPANY | 0363-0423 | 0363-0423-41 | 40 TABLET, COATED in 1 BLISTER PACK (0363-0423-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG;30MG | ||||
| Approval Date: | Apr 17, 2001 | TE: | RLD: | No | |||||
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