Orange Book product
DEXCHLORPHENIRAMINE MALEATE 2MG/5ML **Federal Register determination that product was…
Orange Book ANDA 088251 · PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC · Discontinued
Key facts
| Proprietary name | DEXCHLORPHENIRAMINE MALEATE |
|---|---|
| Active ingredients | DEXCHLORPHENIRAMINE MALEATE |
| Strength | 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA088251 |
| Applicant holder | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Mar 23, 1984 |
At a glance
- None Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.