Drug application
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE)
Drugs@FDA ANDA 088763 · ACTAVIS MID ATLANTIC
Key facts
| Drug name | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
|---|---|
| Active ingredients | CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 088763 |
| Company | ACTAVIS MID ATLANTIC |
| Dosage forms | SYRUP, ORAL |
| Strength | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
| Marketing status | Discontinued |
| TE codes | AA |
| Reference listed drug | Yes |
| Latest submission status date | Oct 31, 1984 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.