Orange Book product
ACETAMINOPHEN AND CODEINE PHOSPHATE 120MG/5ML;12MG/5ML
Orange Book ANDA 085861 · ACTAVIS MID ATLANTIC LLC · Discontinued
Key facts
| Proprietary name | ACETAMINOPHEN AND CODEINE PHOSPHATE |
|---|---|
| Active ingredients | ACETAMINOPHEN, CODEINE PHOSPHATE |
| Strength | 120MG/5ML;12MG/5ML |
| Dosage form | SOLUTION |
| Route | ORAL |
| Application | ANDA085861 |
| Applicant holder | ACTAVIS MID ATLANTIC LLC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jan 1, 1982 |
At a glance
- 1–9 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.