Orange Book product
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE 6MG;120MG
Orange Book ANDA 078648 · AVANTHI INC · Discontinued
Key facts
| Proprietary name | DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE |
|---|---|
| Active ingredients | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE SULFATE |
| Strength | 6MG;120MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA078648 |
| Applicant holder | AVANTHI INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 27, 2013 |
At a glance
- None 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.