Details for New Drug Application (NDA): 090397
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The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There are twenty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.
Summary for 090397
Tradename: | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE |
Applicant: | Bionpharma |
Ingredient: | diphenhydramine hydrochloride; ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 090397
Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 090397
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 090397 | ANDA | WALGREEN COMPANY | 0363-0207 | 0363-0207-11 | 1 BOTTLE in 1 CARTON (0363-0207-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE |
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 090397 | ANDA | WALGREEN COMPANY | 0363-0207 | 0363-0207-15 | 1 BOTTLE in 1 CARTON (0363-0207-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | ||||
Approval Date: | Nov 22, 2010 | TE: | RLD: | No |
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