Orange Book product
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Orange Book ANDA 200888 · ONESOURCE SOFTGELS PTE LTD · Over the counter
Key facts
| Proprietary name | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE |
|---|---|
| Active ingredients | DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN |
| Strength | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT |
| Dosage form | CAPSULE |
| Route | ORAL |
| Application | ANDA200888 |
| Applicant holder | ONESOURCE SOFTGELS PTE LTD |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Mar 5, 2012 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.