Orange Book product
PROMETH VC W/ CODEINE 10MG/5ML;5MG/5ML;6.25MG/5ML
Orange Book ANDA 088764 · CHARTWELL RX SCIENCES LLC · Discontinued
Key facts
| Proprietary name | PROMETH VC W/ CODEINE |
|---|---|
| Active ingredients | CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE |
| Strength | 10MG/5ML;5MG/5ML;6.25MG/5ML |
| Dosage form | SYRUP |
| Route | ORAL |
| Application | ANDA088764 |
| Applicant holder | CHARTWELL RX SCIENCES LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 31, 1984 |
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.