Orange Book product
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML **Federal Register determination that…
Orange Book ANDA 088763 · ACTAVIS MID ATLANTIC LLC · Discontinued
Key facts
| Proprietary name | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
|---|---|
| Active ingredients | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE |
| Strength | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA088763 |
| Applicant holder | ACTAVIS MID ATLANTIC LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Oct 31, 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.