Details for New Drug Application (NDA): 200888
NDA 200888 describes IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, and Onesource, and is included in three NDAs. It is available from fifteen suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.
The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.
The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There is one drug master file entry for this compound. Sixteen 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: | Onesource |
| 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 | TOP CARE (Topco Associates LLC) | 36800-756 | 36800-756-40 | 1 BOTTLE, PLASTIC in 1 BOX (36800-756-40) / 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
