Details for New Drug Application (NDA): 200888
✉ Email this page to a colleague
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 200888
Tradename: | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | diphenhydramine hydrochloride; ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 200888
Mechanism of Action | Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 200888
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 200888 | ANDA | Walgreens | 0363-0756 | 0363-0756-20 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0756-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | diphenhydramine hydrochloride; ibuprofen | CAPSULE;ORAL | 200888 | ANDA | Walgreens | 0363-0756 | 0363-0756-40 | 1 BOTTLE, PLASTIC in 1 BOX (0363-0756-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | ||||
Approval Date: | Mar 5, 2012 | TE: | RLD: | No |
Complete Access Available with Subscription